Immunotherapy + Cabozantinib for Advanced Kidney Cancer

Recruiting at 972 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

Research Team

Tian Zhang

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

This trial is for adults with advanced kidney cancer that hasn't been treated yet. Participants should have a certain level of physical fitness (Karnofsky performance status >= 70%), measurable disease, and be at an intermediate or poor risk according to specific criteria. They can't join if they've had certain treatments before, have active autoimmune diseases, uncontrolled conditions like hypertension or infections like HIV with detectable viral load, or are pregnant.

Inclusion Criteria

You have a disease that can be measured according to the study's guidelines.

My kidney cancer is classified as intermediate or poor risk.

Your hemoglobin level is at least 8 grams per deciliter.

Exclusion Criteria

I haven't had serious stomach or bowel problems in the last 6 months.

I am currently being treated for an autoimmune disease.

Your blood pressure is too high and not under control.

Treatment Details

Interventions

• Cabozantinib (Tyrosine Kinase Inhibitor)
• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview The study compares standard immunotherapy treatment using Nivolumab and Ipilimumab followed by Nivolumab alone versus the same regimen followed by a combination of Nivolumab with Cabozantinib. The goal is to see if adding Cabozantinib improves outcomes in untreated renal cell carcinoma that has spread.

Participant Groups

Group I: Arm B (nivolumab, cabozantinib) Experimental Treatment 8 Interventions

INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. TREATMENT: Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity. Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-CR/non-PD rwith clinical stability eceive nivolumab IV over 30 minutes on day 1 and cabozantinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood and urine sample collection, and may also undergo a bone scan as clinically indicated throughout the study.

Group II: Arm A (nivolumab) Active Control 8 Interventions

INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. TREATMENT: Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-CR/non-PD with clinical stability receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood and urine sample collection, and may also undergo a bone scan as clinically indicated throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+