A phase II trial of tiragolumab in combination with atezolizumab and bevacizumab in patients with previously treated, microsatellite stable, metastatic colorectal adenocarcinoma
The goal of this study is to learn if a new combination treatment is effective for patients with microsatellite stable, advanced colorectal cancer. The study treatment combines 3 drugs: atezolizumab, bevacizumab, and tiragolumab. The main questions the study aims to answer are: Does the study treatment effectively treat colorectal cancer? Is the study treatment safe for patients with colorectal cancer? How does the study treatment effect the immune system in patients with colorectal cancer? Participants in this study will receive the study treatment and undergo checkups, laboratory tests, and imaging tests for monitoring. Some participants will also undergo tumor biopsies.
Why this Research Matters
This is a phase II study investigating the efficacy and safety of a triple-combination immunotherapy regimen in patients diagnosed with microsatellite stable metastatic colorectal cancer (MSS mCRC), refractory to fluorouracil, oxaliplatin, and irinotecan chemotherapy. The trial is designed as a single-arm, Simon two-stage study. All participants will receive a fixed-dose regimen of the three agents: atezolizumab (1200 mg), bevacizumab (15 mg/kg), and tiragolumab (600 mg), administered intravenously on day 1 of 21-day cycles. Treatment response will be assessed by imaging using RECIST v1.1 every 9 weeks. Study treatment will be continued until disease progression, unacceptable toxicity, death, decision by the patient and/or treating physician to withdraw from the study, pregnancy, or study termination, whichever occurs first. This study will enroll patients in 2 cohorts: A and B. Patients in Cohort A will undergo pre-treatment and on-treatment tumor biopsies for correlative studies. Patient in Cohort B will not receive study biopsies. Patients in Cohorts A and B will otherwise receive identical treatment.
Who can Participate
Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study. https://clinicaltrials.gov/study/NCT06784947?term=NCT06784947&rank=1
Study ID
Protocol Number: 24-0547
More information available at ClinicalTrials.gov: NCT06784947
Meet the Team
Principal Investigator