Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma with associated Inferior vena cava tumor thrombus (NEOPAX)

Primary Objective

Evaluate the efficacy of the neoadjuvant Pembrolizumab and Axitinib in reducing the inferior vena cava tumor thrombus (IVC TT) among patients with renal cell carcinoma

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Description

The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can decrease the IVC TT burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.

Details
Age

Adult

Eligibility

In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Participant self-identified gender ages >/= 18 years old is acceptable and appropriate if they meet other inclusion criteria. 4. Histologically proven clear cell component RCC. 5. An upfront candidate for definitive surgery per treating Urologist. 6. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per treating urologist. 7. cT3b, cT3c, cT4 8. cN0 or cN1 9. cM0 or cM1 10. ECOG performance status 0 &#8211; 2. 11. Urinalysis <2+ protein. If dipstick is &#8805;2+ then a 24-hour urine collection should be performed, and the patient may enter the trial if urinary protein is <2g per 24 hours. 12. All participants who have reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days prior to starting trial treatment. Reproductive potential is defined as the following: o Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: &#9642; Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) &#9642; Women &#8805;50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy

In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Participant self-identified gender ages >/= 18 years old is acceptable and appropriate if they meet other inclusion criteria. 4. Histologically proven clear cell component RCC. 5. An upfront candidate for definitive surgery per treating Urologist. 6. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per treating urologist. 7. cT3b, cT3c, cT4 8. cN0 or cN1 9. cM0 or cM1 10. ECOG performance status 0 – 2. 11. Urinalysis <2+ protein. If dipstick is ≥2+ then a 24-hour urine collection should be performed, and the patient may enter the trial if urinary protein is <2g per 24 hours. 12. All participants who have reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days prior to starting trial treatment. Reproductive potential is defined as the following: o Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: ▪ Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) ▪ Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy

Type of Study

Treatment

Scope

Local

Locations

University of Colorado Hospital

Principal Investigator
Photograph of Elizabeth Kessler,  MD

Elizabeth Kessler, MD

Study ID

Protocol Number: 22-1669

More information available at ClinicalTrials.gov: NCT05969496

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