Study on Cabozantinib Combined with Nivolumab and Ipilimumab for Advanced Kidney Cancer

Sponsor: Bradley A. McGregor, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04413123

Provider View

This clinical trial is testing a new combination of drugs—cabozantinib, nivolumab, and ipilimumab—to see if they are safe and effective in slowing down the growth of advanced kidney cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—cabozantinib, nivolumab, and ipilimumab—can safely and effectively slow down the growth of kidney cancer that has advanced or spread. These drugs are not yet approved by the FDA for this type of cancer. About 40 people will participate in this study, which includes screening for eligibility, receiving the study treatment, and attending follow-up visits to monitor health and safety.

Description

This study involves a combination of three investigational drugs: cabozantinib, nivolumab, and ipilimumab. These drugs are not yet approved by the FDA for treating your type of kidney cancer. The study will include several steps: checking if you are eligible, receiving the treatment, and attending follow-up visits to monitor your health and safety. Approximately 40 people will take part in this study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or metastatic non-clear cell renal cell carcinoma (nccRCC), including types like Papillary RCC, Unclassified RCC, and others.
  • Have measurable disease according to specific medical criteria.
  • Aged 18 years or older.
  • In good overall health with a performance status score of 0 or 1.
  • Must provide a fresh tumor biopsy or have available archival tumor tissue.
  • Normal organ and bone marrow function based on specific blood tests.
  • Women and men must agree to use effective birth control during the study and for several months after.
  • Able to understand and willing to sign a consent form.

Exclusion Criteria

  • May have had previous treatments, but only one VEGF-based therapy is allowed.
  • Cannot have had previous treatments with certain immune therapies or cabozantinib.
  • No recent use of certain medications or treatments, including some cancer therapies and hydroxychloroquine.
  • No untreated brain metastases unless treated and stable.
  • No other recent cancers unless they pose a negligible risk.
  • No significant heart problems or uncontrolled high blood pressure.
  • No history of severe allergic reactions to similar drugs.
  • No use of certain immunosuppressive medications recently.
  • No history of autoimmune diseases or certain lung conditions.
  • No active infections like hepatitis B, C, or HIV.
  • No recent live vaccines.
  • No significant bleeding disorders or recent major surgeries.
  • Not pregnant or breastfeeding.

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