Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03866382

Provider View

This clinical trial is exploring a new treatment combination of two immunotherapy drugs, nivolumab and ipilimumab, with a targeted anti-cancer drug, cabozantinib, to see if it can better treat rare genitourinary tumors that have spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing whether a combination of the drugs cabozantinib, nivolumab, and ipilimumab can effectively treat rare genitourinary (GU) tumors that have spread beyond their original location. Cabozantinib may help stop tumor growth by blocking certain enzymes, while nivolumab and ipilimumab are immunotherapy drugs that help the immune system attack cancer cells. The study aims to see if this combination works better than using any of these drugs alone for patients with rare GU tumors that have no other treatment options.

Description

The main goal of this study is to see how well the combination of cabozantinib, nivolumab, and ipilimumab works in treating rare types of genitourinary tumors. Researchers will measure how many patients experience a reduction in tumor size. They will also look at how long patients live without the cancer getting worse and overall survival rates. The study will also assess the safety of this treatment combination and collect tissue samples for future research.

Participants will take cabozantinib by mouth daily and receive nivolumab and ipilimumab through an IV on specific days. The treatment cycles will repeat every 21 days for the first four cycles and every 28 days for the following cycles, continuing for up to two years unless the cancer progresses or side effects become too severe. Patients will undergo regular scans to monitor the cancer's response to treatment.

After completing the treatment, patients will have follow-up visits every two months for up to five years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have cancer that has spread to other parts of the body, with at least one measurable tumor or bone lesion.
  • Diagnosed with specific types of rare genitourinary tumors, such as certain bladder, kidney, or penile cancers.
  • May have received up to two previous cancer treatments or be new to treatment.
  • Be 18 years or older.
  • Able to swallow tablets.
  • Have a good performance status, meaning able to carry out daily activities with minimal assistance.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • HIV-positive patients are eligible if their condition is well-controlled.
  • Certain autoimmune conditions are allowed if well-managed with topical treatments.
  • No recent history of severe gastrointestinal issues or major surgery.
  • No active brain metastases or significant heart conditions.
  • No history of severe allergic reactions to similar drugs.
  • No active infections like hepatitis B or C.
  • No active autoimmune diseases that could worsen with treatment.

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