Nivolumab + Cabozantinib for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byDarren R. Feldman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, nivolumab and cabozantinib, in people with metastatic kidney cancer. Nivolumab helps the immune system attack cancer cells, while cabozantinib blocks signals that help cancer grow. The goal is to see if this combination works better than other treatments.

Eligibility Criteria

This trial is for adults (18+) with advanced or metastatic non-clear cell renal cell carcinoma who've had 0 or 1 prior treatments. They must be able to understand the study, consent to it, and agree to use contraception if fertile. Excluded are those on certain medications, with severe allergies, HIV/hepatitis B/C infections, uncontrolled conditions like hypertension or thyroid issues, recent major surgery, brain/spinal cancer history or significant cardiovascular disease.

Inclusion Criteria

Signed and dated IRB-approved Informed Consent Form

I can provide a tissue sample from my cancer for testing.

My recent blood and organ tests meet the study's requirements.

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Exclusion Criteria

I have a serious wound, ulcer, or bone fracture that is not healing.

My heart's electrical activity (QTcF) is not over 500 ms.

I have lung lesions or disease in my airways.

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Treatment Details

Interventions

Cabozantinib (Tyrosine Kinase Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study tests a combination of two drugs: Nivolumab (Opdivo®) and Cabozantinib (Cabometyx®), in patients with metastatic kidney cancer. It aims to assess the benefits and adverse effects compared to current standard treatments.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Cohort 4: Unclassified, papillary, and HL RCCExperimental Treatment2 Interventions

Cohort 4 is an expansion of Cohorts 1+3, which will accure an additional 40 patients

Group II: Cohort 3: Unclassified, papillary, and HL RCCExperimental Treatment2 Interventions

Cohort 3 is designed as an expansion cohort of Cohort 1 with 20 additional patients to obtain a more precise estimate of the ORR and clinical outcomes

Group III: Cohort 2: Chromophobe RCCExperimental Treatment2 Interventions

Cohort 2 is designed as a Simon's optimal two-stage design with a total possible sample size of 17. This design discriminates between ORR rates of 5 and 25%.

Group IV: Cohort 1: Unclassified, papillary, and HL RCCExperimental Treatment2 Interventions

Cohort 1 is designed as a single stage study with a total sample size of 20. This design discriminates between ORR rates of 10 and 35%.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Cabometyx for: