Study on Sitravatinib and Nivolumab for Treating Advanced Kidney Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04904302

Provider View

This clinical trial is exploring the effects of combining two drugs, sitravatinib and nivolumab, to treat patients with advanced kidney cancer that has spread to other parts of the body. The study aims to see if this combination can help stop cancer growth and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is testing a combination of two drugs, sitravatinib and nivolumab, to treat patients with advanced kidney cancer that has spread. Sitravatinib may help stop cancer cells from growing by blocking certain enzymes, while nivolumab, an immunotherapy drug, may help the immune system attack cancer cells. The goal is to see if using these drugs together can kill more cancer cells and control the disease better.

Description

The main goal of this study is to find out how well the combination of sitravatinib and nivolumab works in controlling advanced kidney cancer. Researchers will measure how many patients experience a reduction in tumor size or disease stabilization after 24 weeks of treatment. They will also look at overall survival rates, how long patients live without the disease getting worse, and how long any positive response lasts.

The study will also assess the safety and side effects of the treatment, as well as its impact on patients' quality of life. Additionally, researchers will explore changes in the immune system and cancer cells before and after treatment.

Participants will take sitravatinib by mouth daily and receive nivolumab through an IV every four weeks. Treatment cycles will continue as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits every three months.

Eligibility Criteria

Inclusion Criteria

  • Have advanced kidney cancer with a clear cell component that has spread and received 1 or 2 previous treatments, including a PD-1 or PD-L1 inhibitor, cabozantinib, or lenvatinib.
  • Show evidence of cancer progression after the last treatment within six months before joining the study.
  • Have at least one measurable tumor that can be tracked using scans.
  • Be in good overall health with a performance status of 70 or higher on the Karnofsky scale.
  • Be 18 years or older.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Patients with controlled brain metastases are eligible if they meet specific conditions.

Exclusion Criteria

  • Have had another type of cancer within the past two years, except for certain non-threatening cancers.
  • Currently receiving or have recently received other cancer treatments within two weeks before joining the study.
  • Have had major surgery or significant injury within 28 days before starting the study treatment.
  • Have a history of severe immune-related side effects from previous treatments.
  • Have active autoimmune diseases or conditions that compromise the immune system.
  • Have uncontrolled medical conditions that could interfere with the study.
  • Be pregnant or breastfeeding, or not using effective birth control if of reproductive potential.
  • Have uncontrolled brain metastases or require ongoing steroid treatment for brain metastases.
  • Have a history of severe heart or lung conditions, uncontrolled diabetes, or active infections.
  • Be unable to comply with study appointments and procedures.

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