S1900B, A Phase II Study of Selpercatinib (LOXO-292) in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)Protocol #: 20-0563 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
EA2187: "A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma"Protocol #: 20-0584 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
Identification of Early Cardiac Injury from Radiation Therapy Using Cardiac MRIProtocol #: 20-0537 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients with Advanced Clear Cell Renal Cell CarcinomaProtocol #: 20-0357 Location: University of Colorado Hospital |
S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"Protocol #: 20-0359 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
NRG-GY022: Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using CarboplatinProtocol #: 20-0360 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATAStudy B7981032 will investigate PF-06651600 in participants with AA. This is a Phase 3, open-label, multi-center, long-term study designed to evaluate the safety and efficacy of PF-06651600 in adults and adolescents 12 years of age. The study will have a maximum duration of approximately 26 months. This includes up to a 5-week screening period, a 24-month open-label treatment period, and a 4-week follow-up period (See Schema). Eligible participants will be given the opportunity to enroll from the index studies B7931005 and B7981015, as well as de novo participants (ie, those who have not previously received study intervention in Study B7931005 or B7981015). Protocol #: 19-2839 Location: University of Colorado Hospital |
An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancerProtocol #: 20-0035 Location: University of Colorado Hospital |
First-In-Human Dose-Escalation Study of STP1002 in Patients with Advanced-Stage Solid TumorsProtocol #: 19-3118 Location: University of Colorado Hospital |
NRG-LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus AtezolizumabProtocol #: 19-2514 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
MRI for Cardiotoxicity in Kids (MOCK)Protocol #: 19-3023 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain DiseaseProtocol #: 19-2833 Locations: Memorial Hospital Central; University of Colorado Hospital |
ADVL1712: A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924, IND#142772) Given in Combination with Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic SyndromeProtocol #: 19-2163 Location: Childrens Hospital Colorado |
S1826: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE greater than or equal to 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMAProtocol #: 19-2950 Location: Childrens Hospital Colorado |
A PHASE 1/2 STUDY OF TPX-0046, A NOVEL ORAL RET/SRC INHIBITOR IN ADULT SUBJECTS WITH ADVANCED/METASTATIC SOLID TUMORS HARBORING ONCOGENIC RET FUSIONS OR MUTATIONSProtocol #: 19-2888 Location: University of Colorado Hospital |
Protocol I5B-MC-Y001(a) An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue SarcomaProtocol #: 19-6133 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung CancerProtocol #: 19-2818 Location: University of Colorado Hospital |
A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).Protocol #: 19-2721 Location: University of Colorado Hospital |
NRG-HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal CancerProtocol #: 19-2326 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
EA3161: A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCCProtocol #: 19-2554 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 MutationProtocol #: 19-2707 Location: University of Colorado Hospital |
Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Doses of DB-020 in Patients Receiving CisplatinProtocol #: 19-2560 Location: University of Colorado Hospital |
A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid SarcomaProtocol #: 19-2564 Location: University of Colorado Hospital |
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLyProtocol #: 19-2631 Location: Childrens Hospital Colorado |
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor TherapyProtocol #: 19-2520 Location: University of Colorado Hospital |
An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted TherapiesProtocol #: 19-2445 Locations: Highlands Ranch Hospital; University of Colorado Hospital |
ACNS1723, A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355)Protocol #: 19-2475 Location: Childrens Hospital Colorado |
A PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY OF AL101 IN PATIENTS WITH ADENOID CYSTIC CARCINOMA (ACC) BEARING ACTIVATING NOTCH MUTATIONSProtocol #: 19-2255 Location: University of Colorado Hospital |
A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]Protocol #: 19-1913 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients with Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) that are Causing Significant MorbidityProtocol #: 19-2270 Location: Childrens Hospital Colorado |
A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)Protocol #: 19-6114 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancerProtocol #: 19-1977 Location: University of Colorado Hospital |
COG AAML18P1 - Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)Protocol #: 19-1839 Location: Childrens Hospital Colorado |
COG AHOD1822 / Merck MK-3475-667: An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)Protocol #: 19-1481 Location: Childrens Hospital Colorado |
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)Protocol #: 19-6513 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
ACNS1721 - A Phase 2 Study of Veliparib (ABT-888, IND #139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E MutationsProtocol #: 19-1633 Location: Childrens Hospital Colorado |
A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination with Atezolizumab in HLA-A 02+ Patients with HPV16+ Recurrent, Locally Advanced or Metastatic Solid TumorsProtocol #: 19-1727 Location: University of Colorado Hospital |
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination with Bevacizumab Compared to Bevacizumab with 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX wit Bevacizumab (LYNK-003)Protocol #: 19-6102 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)Protocol #: 19-1634 Location: Childrens Hospital Colorado |
COG AREN1721 - A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age GroupsProtocol #: 19-1467 Location: Childrens Hospital Colorado |
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects with A+AVD."Protocol #: 19-6510 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract CarcinomaProtocol #: 19-1503 Location: University of Colorado Hospital |
S1800A, A PHASE II RANDOMIZED STUDY OF RAMUCIRUMAB PLUS MK3475 (PEMBROLIZUMAB) VERSUS STANDARD OF CARE FOR PATIENTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP NON-MATCHED SUB-STUDY)Protocol #: 19-1318 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A Phase 1a/b Dose-Finding Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination TherapyProtocol #: 19-1458 Location: University of Colorado Hospital |
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancerProtocol #: 19-6509 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.Protocol #: 19-1337 Locations: Lone Tree Medical Center; University of Colorado Hospital |
An Open label, Phase I/II study to evaluate the safety and efficacy of Tenalisib (RP6530), a novel PI3K dual inhibitor given in combination with a histone deacetylase (HDAC) inhibitor, Romidepsin in adult patients with relapsed/refractory T-cell LymphomaProtocol #: 19-1431 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid TumorsProtocol #: 19-1302 Location: University of Colorado Hospital |
GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GCAR-7213)Protocol #: 19-0744 Location: University of Colorado Hospital |
ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive NeuroblastomaProtocol #: 19-1259 Location: Childrens Hospital Colorado |
Alpha lipoic acid to decrease treatment related pain and side effects during concurrent chemoradiation in HNSCCProtocol #: 19-1081 Locations: Lone Tree Medical Center; University of Colorado Hospital |
The PISCES Study: A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab TreatmentProtocol #: 19-1297 Location: University of Colorado Hospital |
Assessing patient preferences and a clinical tool for evaluating for sexual function in adolescent and young adult survivors of childhood cancerProtocol #: 19-1111 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven AnalysisProtocol #: 19-1121 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast CancerProtocol #: 19-1152 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
S1806: PHASE III RANDOMIZED TRIAL OF CONCURRENT CHEMORADIOTHERAPY WITH OR WITHOUT ATEZOLIZUMAB IN LOCALIZED MUSCLE INVASIVE BLADDER CANCER (Study SWOG/NRG 1806)Protocol #: 19-1154 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of INBRX-105 in Patients with Locally Advanced or Metastatic Solid TumorsProtocol #: 19-1145 Location: University of Colorado Hospital |
SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancerProtocol #: 19-6076 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
NRG-LU003: A BIOMARKER-DRIVEN PROTOCOL FOR PREVIOUSLY TREATED ALK-POSITIVE NON-SQUAMOUS NSCLC PATIENTS: THE NCI-NRG ALK PROTOCOLProtocol #: 19-1146 Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination with Dual Checkpoint Blockade using AGEN1884 and AGEN2034 for Advanced or Metastatic Soft Tissue SarcomasProtocol #: 19-0554 Location: University of Colorado Hospital |
A Phase 1, Open Label, Dose-Escalation and Expansion Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid TumorsProtocol #: 19-1118 Location: University of Colorado Hospital |
A Phase 1b/2 Study of AST-008 Combined with Pembrolizumab or Cemiplimab in Patients with Advanced Solid TumorsProtocol #: 19-1074 Location: University of Colorado Hospital |
A Multicenter, Open-Label, Non-Randomised First in Human Study of NG-350A in Patients with Metastatic or Advanced Epithelial Tumours (FORTITUDE)Protocol #: 19-1147 Location: University of Colorado Hospital |
A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid TumorsProtocol #: 19-1069 Location: University of Colorado Hospital |
LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLSProtocol #: 19-0561 Location: University of Colorado Hospital |
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD 1 STUDY)Protocol #: 19-0967 Location: University of Colorado Hospital |
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant TumorsProtocol #: 19-0604 Location: University of Colorado Hospital |
A Multicenter, Double Blind, Randomized,Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung CancerProtocol #: 19-6065 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk MelanomaProtocol #: 19-0642 Location: University of Colorado Hospital |
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or AblationProtocol #: 19-0820 Location: University of Colorado Hospital |
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of RelapseProtocol #: 19-0905 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated with A+AVDProtocol #: 19-6060 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumorsProtocol #: 19-0556 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.Protocol #: 19-0632 Locations: Lone Tree Medical Center; University of Colorado Hospital |
CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDYProtocol #: 19-0519 Location: University of Colorado Hospital |
A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)Protocol #: 19-0507 Location: University of Colorado Hospital |
A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)Protocol #: 19-0536 Location: Childrens Hospital Colorado |
Phase 1 Dose Escalation and Expansion Cohort Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube CancerProtocol #: 19-0457 Location: University of Colorado Hospital |
A Multi-Center, Open-Label, phase I/Ib, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid TumorsProtocol #: 19-0539 Location: University of Colorado Hospital |
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)A double blind comparison of enzalutamide plus pembrolizumab or placebo in patients with metastatic prostate cancer. Protocol #: 19-0493 Locations: Highlands Ranch Hospital; University of Colorado Hospital |
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naive Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE- 921)A comparison of Pembrolizumab plus Docetaxel versus placebo plus Docetaxel in patients with chemo-naive, metastatic prostate cancer. Protocol #: 19-0473 Locations: Highlands Ranch Hospital; University of Colorado Hospital |
AINV18P1: A Phase I Study of Palbociclib (IND# 141416), a CDK4/6 Inhibitor, in Combination with Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)Protocol #: 19-0549 Location: Childrens Hospital Colorado |
CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCERProtocol #: 19-0476 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter TrialProtocol #: 19-6041 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSSProtocol #: 18-2798 Location: University of Colorado Hospital |
ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL (EMERALD)Protocol #: 19-0327 Location: University of Colorado Hospital |
A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH PEMBROLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED MELANOMAProtocol #: 19-0172 Location: University of Colorado Hospital |
A Phase 1, open label, first-in-human study of TR1801-ADC, an antibody drug conjugate (ADC), in patients with select solid tumors expressing c-MetProtocol #: 19-0232 Location: University of Colorado Hospital |
LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)Protocol #: 19-0267 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Improving physical activity maintenance following an exercise program for cancer survivorsProtocol #: 19-0323 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center |
PHASE I STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PALBOCICLIB (IBRANCE) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS (Pfizer Protocol A5481092/ ADVL1921)Protocol #: 19-0299 Location: Childrens Hospital Colorado |
A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE I-III OPERABLE, ESTROGEN RECEPTOR-POSITIVE BREAST CANCERA PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER Protocol #: 19-0206 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory OsteosarcomaPrimary Objective: (1) Evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Secondary Objectives: (1) Describe the pharmacokinetics (PK) of losartan when given in combination with sunitinib in pediatric and young adult patients with relapsed or refractory osteosarcoma. (2) Describe the pharmacodynamic (PD) effects of losartan and sunitinib, specifically effects on monocyte migration, plasma CCL2 levels, and changes to the peripheral CCR2+ monocyte population, when given in combination in pediatric and adult patients with relapsed or refractory osteosarcoma. (3) Describe the preliminary antitumor activity of losartan in combination with sunitinib in pediatric and adult patients with relapsed or refractory osteosarcoma. Exploratory Objectives: (1) Describe changes to peripheral T cell populations including CD4+, CD8+, and regulatory T cells, which occurs with treatment of losartan and sunitinib. (2) Describe changes to peripheral immune-related cytokines/chemokines such as TGF-β, IFNγ and VEGF with treatment of losartan and sunitinib. (3) Characterize tumor-infiltrating leukocytes, micro-vessel density, and immune-related gene expression in resected pulmonary metastases of patients treated with losartan and sunitinib. Protocol #: 18-2740 Locations: Childrens Healthcare of Atlanta; Childrens Hospital Colorado; University of Colorado Hospital |
An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid TumorsProtocol #: 19-0207 Location: University of Colorado Hospital |
A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON SMALL CELL LUNG CANCERProtocol #: 19-0127 Location: University of Colorado Hospital |
Creation of a comprehensive database of cancer survivors participating in an exercise program (BFitBwell)Protocol #: 16-0692 Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center |
AREN1721: A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age GroupsA comparison of Axitinib plus Nivolumab vs Axitinib vs Nivolumab in treatment of unresectable kidney cancer Protocol #: 19-0048 Location: University of Colorado Hospital |
The MAP TRIAL: PHASE III STUDY OF MUSCADINE PLUS (MPX) IN MEN WITH PROSTATE CANCER: A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF MPX CAPSULES ON RISING PROSTATE-SPECIFIC ANTIGEN LEVELS IN ALANINE/ALANINE SOD2 GENOTYPE MEN FOLLOWING INITIAL THERAPY FOR PROSTATE CANCERA double blind comparison of MPX versus placebo in men with prostate cancer. Protocol #: 18-2604 Location: University of Colorado Hospital |
Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the assessment of radiation therapy outcome for liver cancer patientsProtocol #: 18-2874 Location: University of Colorado Hospital |
A randomized, multicenter, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancerProtocol #: 18-6515 Location: Memorial Hospital Central |
A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene FusionsProtocol #: 19-0011 Location: University of Colorado Hospital |
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER-positive, HER2 negative Advanced Breast Cancer (SERENA-1)Protocol #: 18-2654 Location: University of Colorado Hospital |
A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid TumorsProtocol #: 18-2520 Locations: Lone Tree Medical Center; University of Colorado Hospital |
PHASE II, DOUBLE-BLIND, RANDOMIZED TRIAL OF AVOVA-1 (AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR ASSOCIATED ANTIGENS) VS. AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (MC) IN PATIENTS WITH STAGE III OR IV EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA AFTER PRIMARY THERAPYProtocol #: 18-2569 Location: University of Colorado Hospital |
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)Protocol #: 18-2692 Location: University of Colorado Hospital |
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C MutationProtocol #: 18-2529 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial SarcomaProtocol #: 18-2646 Location: University of Colorado Hospital |
A Randomized Study of Breast Cancer Patient Engagement with Patient Reported Outcome Measure Survey ResultsProtocol #: 18-2562 Locations: Cherry Creek Medical Center; Lone Tree Medical Center; University of Colorado Hospital |
A Stepped Care Intervention to Reduce Disparities in Mental Health Services among Underserved Lung and Head-and-Neck Cancer Patients and their Caregivers.Protocol #: 16-2621 Locations: Denver Health Medical Center; National Jewish Health; University of Colorado Hospital |
A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA- A0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer.Protocol #: 18-2404 Location: University of Colorado Hospital |
Predictors of physical activity maintenance in colorectal cancer survivorsSupervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions. Protocol #: 18-2436 Locations: Anschutz Health and Wellness; Colorado State University; Harmony Campus; Poudre Valley Hospital; UCD Anschutz Health & Wellness Center |
A Phase 2, multicenter, open-label, 2-cohort study of trastuzumab deruxtecan (DS-8201a), an anti-HER2 antibody drug conjugate (ADC), for HER2-over-expressing or -mutated, unresectable and/or metastatic non-small cell lung cancer (NSCLC)Protocol #: 18-2488 Location: University of Colorado Hospital |
Evaluation of Sun Protection Education using the Reveal Imager Photo-aging and the SPA QuestionnaireProtocol #: 17-2424 Locations: University of Colorado Cancer Center; University of Colorado Hospital |
Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): a phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancerProtocol #: 18-2209 Location: University of Colorado Hospital |
Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma (Phase I and II) and other solid tumors (Phase I only).Protocol #: 18-2382 Location: University of Colorado Hospital |
PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrationsThis is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dose escalation cohort is designed to determine the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of savolitinib. Once the MTD/RP2D is determined, the enrollment for an efficacy expansion cohort will open for patients whose tumors harbor genetic MET activation as determined by CLIA tests performed at participating sites, and confirmed by FDA approved tests. Protocol #: 18-2432 Location: Childrens Hospital Colorado |
A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 MutationProtocol #: 18-2219 Location: University of Colorado Hospital |
Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment NaiveProtocol #: 18-2284 Location: University of Colorado Hospital |
A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)Protocol #: 18-2198 Location: University of Colorado Hospital |
A PHASE 1 STUDY OF OKI-179 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED SOLID TUMORSProtocol #: 18-1816 Location: University of Colorado Hospital |
S1802: PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCERA comparison of standard systemic therapy versus standard systemic therapy plus surgery or radiation therpy Protocol #: 18-2252 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A PHASE 1 STUDY OF FOR46 ADMINISTERED EVERY 21 DAYS IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)Protocol #: 18-2354 Location: University of Colorado Hospital |
Phase I trial of indoximod in combination with temozolomide-based therapy for children with progressive primary brain tumors (NLG2105)Protocol #: 18-2309 Location: Childrens Hospital Colorado |
An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin LymphomaProtocol #: 18-6510 Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted TherapyProtocol #: 18-1919 Location: University of Colorado Hospital |
A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with ImatinibProtocol #: 18-1856 Location: University of Colorado Hospital |
Randomized phase II trial of osimertinib with or without local consolidation therapy (LCT) for patients with EGFR-mutant metastatic NSCLC (NORTHSTAR)Protocol #: 18-2051 Location: University of Colorado Hospital |
A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related GenesProtocol #: 18-1933 Locations: Lone Tree Medical Center; University of Colorado Hospital |
Identifying Predictors of Poor Health-Related Quality-of-Life among Pediatric Hematopoietic Stem Cell DonorsProtocol #: 18-1997 Location: Childrens Hospital Colorado |
Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense RegimenProtocol #: 18-6061 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies |
COG ACCL10P1 - Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot StudyProtocol #: 18-2000 Location: Childrens Hospital Colorado |
An Open-Label, Multicenter, First-in-Human, Dose-Escalation Phase 1 Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including SarcomasProtocol #: 18-1672 Location: University of Colorado Hospital |
A multicenter, randomized, double-blinded, placebo-controlled, Phase 3 trial of adjuvant Avelumab (anti-PDL-1 antibody) in Merkel cell carcinoma patients with clinically detected lymph node metastasesProtocol #: 18-1734 Location: University of Colorado Hospital |
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung CancerProtocol #: 18-1728 Location: University of Colorado Hospital |
Square wave testosterone therapy in castration resistant prostate cancerFeasibility of the administration of transdermal testosterone alternating with enzalutamide and the effects it has in the treatment of prostate cancer Protocol #: 18-0821 Location: University of Colorado Hospital |
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell CarcinomaProtocol #: 18-1599 Location: University of Colorado Hospital |
Phase 1, two-part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumorsProtocol #: 18-1721 Locations: Greeley Campus; Highlands Ranch Hospital; University of Colorado Hospital |
An Investigator-Sponsored, Phase 1/2 trial of the oral XPO1 inhibitor selinexor (KPT-330) in combination with docetaxel for previously treated, advanced KRAS mutant non-small cell lung cancer (NSCLC)Protocol #: 18-0554 Location: University of Colorado Hospital |
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - Sponsor Protocol No. CA045-001Protocol #: 18-1343 Location: University of Colorado Hospital |
Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural MesotheliomaProtocol #: 18-1654 Location: University of Colorado Hospital |
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36, for Intratumoral Injection Alone and in Combination with Immune Checkpoint BlockadeProtocol #: 18-1526 Location: University of Colorado Hospital |
COG ACCL1633 - The Effectiveness of Lactobacillus plantarum (LBP, IND# 17339) in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)Protocol #: 18-1349 Location: Childrens Hospital Colorado |
EA2165 A Randomized Phase II Study of Nivolumab after Combined Modality Therapy (CMT) in High Risk Anal CancerProtocol #: 18-1216 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital |
An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects 1 and 30 Years of Age with Relapsed/Refractory Precursor B-cell or T-cell Acute Lympholastic Leukemia or Lymphoblastic LymphomaProtocol #: 18-0867 Location: Childrens Hospital Colorado |
AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE Ib/II TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMAProtocol #: 18-1439 Locations: Lone Tree Medical Center; University of Colorado Hospital |
Acceptance and Commitment Therapy for Chronic Pain in Cancer SurvivorsPrimary Objective: To evaluate the effectiveness of an 8-week, group-based, Acceptance and Commitment Therapy (ACT) intervention for chronic pain management in cancer survivors who have completed active treatment. Secondary Objective: To evaluate the implementation of an 8-week, group-based, ACT intervention for chronic pain management in cancer survivors who have completed active treatment. Protocol #: 18-1102 Location: University of Colorado Hospital |
A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic CancerProtocol #: 18-1347 Location: University of Colorado Hospital |
Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid TumorsProtocol #: 18-1263 Location: University of Colorado Hospital |
Effect of guided imagery for radiotherapy-related distress: A randomized controlled trial for patients with head and neck cancerProtocol #: 18-1100 Location: University of Colorado Hospital |
Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High Risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716) Sponsor Protocol No. MK-3475-716Protocol #: 18-1199 Location: University of Colorado Hospital |
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid TumorsProtocol #: 18-6055 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
Nivolumab with standard of care chemotherapy for the first line treatment of peripheral T cell lymphomaProtocol #: 18-0708 Locations: City of Hope Cancer Center; Lone Tree Medical Center; Thomas Jefferson University Hospital Cancer Center; University of Colorado Hospital |
An open-label, Phase I study to assess the safety of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients.Protocol #: 18-1093 Location: University of Colorado Hospital |
A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors. Protocol v.1.3Protocol #: 18-1150 Location: University of Colorado Hospital |
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145/LN-145-S1) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and NeckProtocol #: 18-1049 Location: University of Colorado Hospital |
Safety and Efficacy of Venetoclax and Azacitidine for Newly Diagnosed Non-Elderly Adult Patients (aged 18-59) with Acute Myeloid LeukemiaProtocol #: 18-0709 Location: University of Colorado Hospital |
Phase I/Ib trial of radiotherapy in combination with Durvalumab (MEDI4736) prior to surgical resection for HPV negative squamous cell carcinoma of the head and neck (HNSCC)Protocol #: 18-0606 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital |
Concomitant Omacetaxine Mepesuccinate and Azacitidine for Patients with Previously Untreated High Grade Myelodysplastic SyndromesProtocol #: 17-2215 Location: University of Colorado Hospital |
COG ANBL1531 - A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)Protocol #: 18-0971 Location: Childrens Hospital Colorado |
A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3021 IN PATIENTS WITH ADVANCED SOLID TUMORSProtocol #: 18-0685 Location: University of Colorado Hospital |
RT CHARM: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTIONProtocol #: 18-0627 Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
Effects of Cannabis Use in Cancer Patients: A Feasibility StudyProtocol #: 18-0836 Locations: University of Colorado Hospital; University of Colorado, Boulder |
PBTC-048: Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and EpendymomaProtocol #: 18-0498 Location: Childrens Hospital Colorado |
NANT 2013-01 A Phase I Dose Escalation Study of Autologous Expanded Natural Killer (NK) Cells for Immunotherapy of Relapsed Neuroblastoma with Dinutuximab +/- Lenalidomide. A New Approaches To Neuroblastoma Therapy (NANT) Treatment ProtocolProtocol #: 18-0686 Location: Childrens Hospital Colorado |
A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancerThis is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer. Protocol #: 18-0567 Locations: Fox Chase Cancer Center; University of Colorado Hospital; University of Pennsylvania |
NANT 2017-01: A Phase I Study of 131I-MIBG with Dinutuximab for Relapsed/Refractory NeuroblastomaProtocol #: 18-0501 Location: Childrens Hospital Colorado |
NRG GU-005:PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCERProtocol #: 18-0285 Locations: Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Impact of Oral mCRPC Therapies Stewardship Pilot Program for VeteransProtocol #: 18-0167 Location: Rocky Mountain Regional VA Medical Center |
COG ANHL1522 - A Pilot Study of Rituximab (RTX) and Third Party Latent Membrane Protein (LMP)-specific Cytotoxic T-Lymphocytes (LMP-TC, IND # 17068) in Pediatric Solid Organ Recipients (SOT) with EBV-Positive CD20-Positive Post-Transplant Lymphoproliferative Disease (PTLD)Protocol #: 18-0198 Location: Childrens Hospital Colorado |
Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to CisplatinProtocol #: 18-0286 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Poudre Valley Hospital; University of Colorado Hospital |
EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms. Protocol #: 18-0392 Locations: Highlands Ranch Hospital; University of Colorado Hospital |
A PHASE 1 MULTI-CENTER DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY AND EARLY EFFICACY OF TBX-3400 IN PATIENTS WITH STAGE III AND IV MELANOMA RESISTANT OR REFRACTORY TO IMMUNE CHECKPOINT INHIBITORSProtocol #: 18-0385 Location: University of Colorado Hospital |
A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naive Children with Unresectable or Progressive Low Grade Glioma (LGG)Protocol #: 16-2322 Location: Childrens Hospital Colorado |
Phase II study of pembrolizumab in combination with binimetinib and bevacizumab in patients with refractory colorectal cancerProtocol #: 17-0466 Location: University of Colorado Hospital |
ADVL1615: A Phase I Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid TumorsProtocol #: 18-0017 Location: Childrens Hospital Colorado |
A PHASE Ia/Ib, MULTICENTER, OPEN-LABEL, DOSE ESCALATION, DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-9545 ALONE OR IN COMBINATION WITH PALBOCICLIB AND/OR LHRH AGONIST IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCERProtocol #: 17-2208 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination with AvelumabProtocol #: 18-0187 Location: University of Colorado Hospital |
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid TumorsProtocol #: 18-0033 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Novel Lung Function Imaging Modality as a Preoperative Evaluation Tool (LIME)Protocol #: 17-2216 Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
A Phase 1/2 First-in-human Study of BMS-986258 Alone and in Combination with Nivolumab in Advanced Malignant TumorsProtocol #: 18-0031 Locations: Lone Tree Medical Center; University of Colorado Hospital |
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax-AXL-ADC) in patients with solid tumorsProtocol #: 17-2451 Location: University of Colorado Hospital |
PBTC-051: Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma1.1 Primary Objectives 1.1.1 To evaluate the safety of APX005M administered intravenously every 3 weeks to children with central nervous system tumors. 1.1.2 To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M. 1.1.3 To determine the pharmacokinetics of APX005M. 1.2 Secondary Objective 1.2.1 To make a preliminary assessment of efficacy via overall response rate, duration of response, progression-free survival and overall survival for DIPG patients. 1.3 Exploratory Objectives 1.3.1 To assess the incidence of anti-drug antibodies. 1.3.2 To determine the immune pharmacodynamics of APX005M. 1.3.3 To identify tumor and blood efficacy and/or resistance biomarkers. Protocol #: 17-2394 Location: Childrens Hospital Colorado |
A Phase I Trial of AZD9291 and Necitumumab in EGFR-Mutant Non-Small Cell Lung Cancer After Progression on a Previous EGFR Tyrosine Kinase InhibitorProtocol #: 17-2381 Location: University of Colorado Hospital |
A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATIONA PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION Protocol #: 17-2078 Location: University of Colorado Hospital |
APEC1621-MASTER, NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)Protocol #: 17-2168 Location: Childrens Hospital Colorado |
A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3011 IN PATIENTS WITH ADVANCED SOLID TUMORSProtocol #: 17-2450 Locations: Lone Tree Medical Center; University of Colorado Hospital |
PBTC-039: Phase II study of Peginterferon alfa-2b (SYLATRON) for pediatric patients with unresectable or recurrent craniopharyngiomaProtocol #: 17-2257 Location: Childrens Hospital Colorado |
COG AALL1631 - International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbonesProtocol #: 17-2213 Location: Childrens Hospital Colorado |
A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid MalignanciesProtocol #: 17-2074 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558)in Advanced Solid Tumors.Protocol #: 17-2164 Location: University of Colorado Hospital |
Open label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma (Merck-Serono Protocol MS100070-0306Protocol #: 17-1845 Location: Childrens Hospital Colorado |
A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with Non-Small Cell Lung Cancer with High PD-L1 ExpressionProtocol #: 17-1778 Location: University of Colorado Hospital |
S1613: A RANDOMIZED PHASE II STUDY OF TRASTUZUMAB AND PERTUZUMAB (TP) COMPARED TO CETUXIMAB AND IRINOTECAN (CETIRI) IN ADVANCED/METASTATIC COLORECTAL CANCER (MCRC) WITH HER-2 AMPLIFICATIONProtocol #: 17-2125 Locations: Greeley Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
ACNS1422 - A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma PatientsProtocol #: 17-1993 Location: Childrens Hospital Colorado |
ARST1431 - A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)Protocol #: 17-1992 Location: Childrens Hospital Colorado |
A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch RepairProtocol #: 17-2036 Locations: Greeley Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid TumorsProtocol #: 17-1808 Location: University of Colorado Hospital |
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)Protocol #: 17-1756 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital |
TACL 2016-001: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin LymphomaProtocol #: 17-1481 Location: Childrens Hospital Colorado |
PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers with or without a History a Lung CancerSubjects will receive treatment with nivolumab as a 30 minute IV infusion on Day 1 of a treatment cycle every two weeks (14 days). There will be no dose escalations or reductions allowed. Treatment may be delayed for up to a maximum of 2 weeks from the scheduled re-treatment date. Subjects may be dosed no less than 12 days from the previous dose. Protocol #: 17-1492 Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital |
PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory diffuse intrinsic pontine glioma (DIPG), non-brainstem high-grade gliomas (NB-HGG), ependymoma, medulloblastoma or hypermutated brain tumorsProtocol #: 17-1991 Location: Childrens Hospital Colorado |
S1616, A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 AgentProtocol #: 17-1834 Locations: Greeley Campus; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital |
Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)Protocol #: 17-1406 Location: Childrens Hospital Colorado |
PBTC-029: A Phase I and Phase II Re-Treatment Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade GliomaProtocol #: 17-1790 Location: Childrens Hospital Colorado |
A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma (BAY 80-6946 /19176)Protocol #: 17-1495 Location: Childrens Hospital Colorado |
A Phase I/Ib Study of sEphB4-HSA in Combination with Chemotherapy or Cetuximab and Radiation Therapy in Patients with Intermediate to High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and NeckProtocol #: 16-2575 Location: University of Colorado Hospital |
A Phase 1b Multi-cohort Study of the Combination of Pembrolizumab (MK-3475) plus Binimetinib alone or the Combination of Pembrolizumab plus Chemotherapy with or without Binimetinib in Participants with Metastatic Colorectal Cancer (KEYNOTE-651)Protocol #: 17-1021 Location: University of Colorado Hospital |
A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic MelanomaProtocol #: 17-1474 Locations: Lone Tree Medical Center; University of Colorado Hospital |
ADVL1514: A Phase I Study of ABI-009 (Nab-Rapamycin) in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination with Temozolomide and IrinotecanProtocol #: 17-1376 Location: Childrens Hospital Colorado |
A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancerTo evaluate the use of Enfortumab vedotin plus CPI in treatment of advanced bladder cancer Protocol #: 17-1410 Location: University of Colorado Hospital |
PROSPECTIVE, LONGITUDINAL, NON-INTERVENTIONAL STUDY OF DISEASE BURDEN AND TREATMENT OF PATIENTS WITH LOW-RISK MYELOFIBROSIS (MF) OR HIGH-RISK ESSENTIAL THROMBOCYTHEMIA (ET) OR ET PATIENTS RECEIVING ET-DIRECTED THERAPYProtocol #: 17-6155 Location: Memorial Hospital Central |
Anal Cancer/HSIL Outcomes Research (ANCHOR) StudyProtocol #: 15-1466 Locations: Denver Health Medical Center; University of Colorado Hospital |
AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell TumorsProtocol #: 17-1043 Location: Childrens Hospital Colorado |
A Phase I Study of Stereotactic Body Radiation Therapy for Patients with Limited Locoregional Recurrences of Ovarian and Uterine Serous CarcinomaProtocol #: 17-1333 Locations: Lone Tree Medical Center; University of Colorado Hospital |
E7080-A001-216: A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS TumorsProtocol #: 17-1165 Location: Childrens Hospital Colorado |
A Phase I Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies (M13-833)Protocol #: 17-0564 Location: Childrens Hospital Colorado |
AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#TBD) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)Protocol #: 17-1086 Location: Childrens Hospital Colorado |
Serum Acetaminophen-Cystein (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations with Liver-Directed Therapy Intended to Treat Hepatic TumorsThis study aims to describe protein adduct (an experimental biomarker of acetaminophen exposure) concentrations in patients taking therapeutic doses of acetaminophen who develop a liver injury from a cause other than acetaminophen. To describe serum acetaminophen-cysteine adduct (an experimental biomarker of acetaminophen exposure) concentrations following hepatic embolization in patients taking therapeutic doses of acetaminophen three days before the procedure Protocol #: 16-0031 Locations: Denver Health Medical Center; University of Colorado Hospital |
ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare TumorsProtocol #: 17-1045 Location: Childrens Hospital Colorado |
A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic TumorsProtocol #: 17-0991 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator's Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal MelanomaProtocol #: 17-0996 Location: University of Colorado Hospital |
A Phase I Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid TumorsProtocol #: 17-0948 Location: University of Colorado Hospital |
A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced MalignanciesProtocol #: 17-0500 Locations: Lone Tree Medical Center; University of Colorado Hospital |
CA209744: Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response.Protocol #: 17-0401 Location: Childrens Hospital Colorado |
NANT 2015-02: PHASE 1 STUDY OF LORLATINIB (PF-06463922), AN ORAL SMALL MOLECULE INHIBITOR OF ALK/ROS1, FOR PATIENTS WITH ALK-DRIVEN RELAPSED OR REFRACTORY NEUROBLASTOMAProtocol #: 17-0511 Location: Childrens Hospital Colorado |
Phase 1 trial of ZW25 in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancersProtocol #: 17-0512 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects with Advanced MalignanciesProtocol #: 17-0402 Location: University of Colorado Hospital |
EA8143: A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)A comparison of Nivolumab vs no Nivolumab prior to nephrectomy. Protocol #: 17-0406 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
NRG-GU002, PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXELA comparison of adjuvant radiotherapy + androgen therapy after a radical prostatectomy with and without Docetaxel. Protocol #: 17-0266 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital |
S1609, DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare TumorsProtocol #: 17-0280 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
A Phase I/II, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA-2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients with Advanced MalignanciesProtocol #: 17-0074 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH-1, IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA WHO EXPERIENCED PROGRESSION OF DISEASE ON HEDGEHOG PATHWAY INHIBITOR THERAPY, OR WERE INTOLERANT OF PRIOR HEDGEHOG PATHWAY INHIBITOR THERAPYProtocol #: 16-2696 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A PHASE 1, DOSE ESCALATION STUDY OF ALX148 IN PATIENTS WITH ADVANCED SOLID TUMORS AND LYMPHOMAProtocol #: 16-2248 Locations: Lone Tree Medical Center; University of Colorado Hospital |
CA018003: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)Protocol #: 16-2449 Location: University of Colorado Hospital |
CRIZOTINIB (XALKORI) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULESProtocol #: 16-2544 Location: Childrens Hospital Colorado |
A Phase 1, Dose Escalation Study of Intravenous TK216 in Patients with Relapsed or Refractory Ewing SarcomaProtocol #: 16-2158 Location: Childrens Hospital Colorado |
Phase I/II Study of Pembrolizumab and Cabozantinib in Patients with Metastatic Renal Cell CarcinomaTo assess the efficacy of Prmbrolizumab plus Cabozantinib in patients with metastatic renal cell carcinoma Protocol #: 16-2300 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
ARM Study: A phase II trial to evaluate crizotinib in the neoadjuvant setting in non-small cell lung cancer patients with surgically resectable, ALK, ROS1, or MET-oncogene positive non-small cell lung cancerProtocol #: 16-2025 Locations: Lone Tree Medical Center; University of California San Francisco; University of Colorado Hospital |
An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin LymphomaProtocol #: 16-2269 Location: Childrens Hospital Colorado |
Is disruption of the human gut microbial environment associated with cognitive impairment following chemotherapy for breast cancer?Protocol #: 16-2138 Location: University of Colorado Hospital |
ADVL1414: A PHASE 1 STUDY OF SELINEXOR (KPT-330, IND #125052), A SELECTIVE XPO1 INHIBITOR, IN RECURRENT AND REFRACTORY PEDIATRIC SOLID TUMORS, INCLUDING CNS TUMORSProtocol #: 15-1936 Location: Childrens Hospital Colorado |
NEWLY DIAGNOSED CHILDREN (LESS THAN 10 YEARS OLD) WITH MEDULLOBLASTOMA AND OTHER CENTRAL NERVOUS SYSTEM EMBRYONAL TUMORS: CLINICAL AND MOLECULAR RISK-TAILORED INTENSIVE AND COMPRESSED INDUCTION CHEMOTHERAPY FOLLOWED BY CONSOLIDATION WITH EITHER SINGLE CYCLE (LOW RISK PATIENTS) OR RANDOMIZATION (HIGH RISK PATIENTS) TO EITHER SINGLE-CYCLE or TO THREE TANDEM CYCLES OF MARROW-ABLATIVE CHEMOTHERAPY WITH AUTOLOGOUS HEMATOPOIETIC PROGENITOR CELL RESCUEProtocol #: 16-1804 Location: Childrens Hospital Colorado |
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway Mutant Acute Lymphoblastic LeukemiaProtocol #: 16-1970 Location: Childrens Hospital Colorado |
PHASE 2 STUDY OF ALISERTIB AS A SINGLE AGENT IN RECURRENT OR PROGRESSIVE CENTRAL NERVOUS SYSTEM (CNS) ATYPICAL TERATOID RHABDOID TUMORS (AT/RT) AND EXTRA-CNS MALIGNANT RHABDOID TUMORS (MRT) AND IN COMBINATION THERAPY IN NEWLY DIAGNOSED AT/RT (SJATRT)Protocol #: 15-1302 Location: Childrens Hospital Colorado |
Phase l-ll Study of MEK 162 for Children with Low-Grade Gliomas and Other Ras/Raf/ERK Pathway Activated TumorsProtocol #: 16-1205 Location: Childrens Hospital Colorado |
MAINTENANCE OBINUTUZUMAB FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA COMPLETE RESPONDERSProtocol #: 16-1217 Location: University of Colorado Hospital |
AR22.001 Vigilant ObservatIon of G1IadeL Wafer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel Wafer (Carmustine Implant) Used in Usual Medical PracticeProtocol #: 15-2153 Location: University of Colorado Hospital |
Randomized Phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/Her2- breast cancerProtocol #: 16-1042 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; Memorial Sloan Kettering Cancer Center; University of Colorado Hospital; West Cancer Center |
A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic or Minimally Symptomatic Non-Metastatic Prostate Cancer Patients with Rising PSAThe objective is to study the effects of GSE (Grape Seed Extract) on patients with Prostate cancer Protocol #: 16-0607 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital |
051/02 A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)Protocol #: 16-0064 Location: Childrens Hospital Colorado |
A Phase 1/2, Open-Label, Dose-Escalation and Expansion study of Entrectinib (RXDX-101) in Pediatrics with Locally Advanced or Metastatic Solid or Primary CNS Tumors and/or Who Have No Satisfactory Treatment OptionsProtocol #: 16-0749 Location: Childrens Hospital Colorado |
A Phase II Single-Arm Study of Therapeutic lobenguane (131I) for Relapsed, High-Risk Neuroblastoma Subjects (OPTIMUM TRIAL)Protocol #: 16-0742 Location: Childrens Hospital Colorado |
NRG-GY005: A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)Protocol #: 16-0708 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
AAML1531 Risk-stratified Therapy for Acute Myeloid Leukemia in Down SyndromeProtocol #: 16-0709 Location: Childrens Hospital Colorado |
LCCC 1523: Phase 2 Trial of Brigatinib after Treatment with Next-Generation ALK inhibitors in Refractory ALK Rearranged NSCLCProtocol #: 16-0506 Location: University of Colorado Hospital |
NRG-GY006: A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal CancerProtocol #: 16-0493 Locations: Lone Tree Medical Center; University of Colorado Hospital |
INTense Exercise foR surviVAL among Men with Metastatic Prostate Cancer (INTERVAL GAP4): A Multicenter, Randomised, Controlled Phase III StudyA comparison of exercise versus no exercise in men with Metastatic Castrate-Resistant Prostate Cancer. Protocol #: 16-0227 Location: University of Colorado Hospital |
ANHL12P1 A Randomized Phase II Trial of Brentuximab Vedotin (SGN35, NSC# 749710) or Crizotinib (NSC# 749005, commercially labeled) in Combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Large Cell Lymphoma (ALCL) IND#117117Protocol #: 15-1921 Location: Childrens Hospital Colorado |
Multicenter Cohort Study To Evaluate Outcomes after Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (iCat) Recommendations in Children and Young Adults with Solid Tumors: The iCat2, GAIN Consortium StudyProtocol #: 16-0216 Location: Childrens Hospital Colorado |
15-2316 Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Targeted Therapy in patients with EGFR, ALK, ROS1 or BRAF mutationsThe primary objective is to 1- Identify differences between pretreatment and early treatment tumor samples in patients whose tumors contain activating mutations and who will be treated with targeted agents as first-line therapy. a. Measurement of gene expression signatures of pre-and early treatment tumors b. Measurement of immunohistochemistry biomarkers of pre- and early treatment tumors tumors Secondary Objectives: 2- Identify pre-therapy predictive markers that can be used to determine which tumors will undergo EMT or activation of other bypass pathways following targeted therapy. 3- Determine if there is a correlation between the depths of tumor response (by RECIST v1.1) (percentage decrease in tumor size) with the presence of an EMT signature. 4- Estimate success rate of early rebiopsy in obtaining tumor samples that have evaluable material for RNA Seq and other analyses. 5- Determine adverse event rate associated with rapid second biopsy Exploratory Objectives: 6- Determine if there is an association between progression free survival and bypass pathway activation status 7- Determine whether there is evidence of bypass pathway activation in circulating tumor cells. Enrolled subjects will be asked to have one - two research tumor biopsies of predetermined target lesions. If they do not have tissue from the target lesion that was previously collected, they will be asked to allow study investigators to use the tissue as part of this study and will have one biopsy before they begin their targeted therapy, and the second biopsy about two weeks later. The subject may also have a third SOC biopsy if tumor progresses. Protocol #: 15-2316 Locations: Lone Tree Medical Center; University of Colorado Hospital |
14-1076 Molecular Biology and Phase I Study of GM-CSF and Intrathecal Trastuzumab in Children with Recurrent EpendymomaProtocol #: 14-1076 Location: Childrens Hospital Colorado |
EZH-102 A Phase I Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial SarcomaProtocol #: 15-1825 Location: Childrens Hospital Colorado |
RXDX-101-02 An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene RearrangementProtocol #: 15-1574 Location: University of Colorado Hospital |
EAY131 Molecular Analysis for Therapy Choice (MATCH)Protocol #: 15-1111 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer (ORIEN)Protocol #: 15-1110 Locations: Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
ML28897/PRO 02 MY PATHWAY: An Open-Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients who have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of these AgentsProtocol #: 15-0801 Location: University of Colorado Hospital |
Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Adenocarcinoma with Molecular CorrelatesProtocol #: 15-0150 Locations: Dana Farber Cancer Institute; Lone Tree Medical Center; Mayo Clinic, Arizona; New York University; University of Arizona Cancer Center; University of Colorado Hospital; University of Kansas Cancer Center |
Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving DexamethasoneProtocol #: 14-1764 Location: University of Colorado Hospital |
E4512 A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion ProteinThis is a double-blind clinical trial of Crizotinib(investigational) that will be administered orally. Protocol #: 14-1915 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
PT-112-101 A Phase I, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-122 Injection in Subjects with Advanced Solid TumorsThis is a clinical trial of PT-112 that will be administered injection which is investigational. Protocol #: 14-0151 Location: University of Colorado Hospital |
RTOG 1304/NSABP B-51/Endorsed Study: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant ChemotherapyThis is a clinical trial of radiation that will be administered after a lumpectomy, to the breast and lymph nodes or mastectomy, to the area where the breast used to be and lymph nodes. This is done to see if giving radiation as described above will help women live longer. Protocol #: 13-2454 Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
RTOG 1008: A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland TumorsThis is a clinical trial of cisplatin that will be administered by IV which is standard of care and radiation therapy that will be administered standard of care. Protocol #: 13-2078 Location: University of Colorado Hospital |