Phase II Study of Immunotherapy for Patients with Renal Medullary Carcinoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05347212

Provider View

This clinical trial is exploring whether a combination of two immunotherapy drugs, nivolumab and relatlimab, can help control renal medullary carcinoma (RMC) that is advanced or has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to find out if the combination of nivolumab and relatlimab can improve the response rate in patients with advanced or metastatic renal medullary carcinoma (RMC). Researchers will measure how many patients experience a significant reduction in tumor size. The study also looks at the safety of the treatment, how long patients live without the disease getting worse, and overall survival. Additionally, the study will explore potential markers that might predict how well patients respond to the treatment.

Description

This study is testing a combination of two immunotherapy drugs, nivolumab and relatlimab, to see if they can help treat renal medullary carcinoma (RMC) that is advanced or has spread. The main goal is to see if more patients experience a reduction in tumor size compared to past treatments. Researchers will also look at how safe the treatment is, how long patients live without the disease getting worse, and overall survival rates. They will also study potential markers that might predict how well patients respond to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic renal medullary carcinoma (RMC) confirmed by a specialist.
  • Can participate whether or not you have had kidney surgery.
  • Must have at least one tumor that can be measured by scans.
  • Willing to provide a new biopsy sample, unless a recent sample is available.
  • Can have had previous treatments, but not with certain immune therapies.
  • Must show disease progression after the last treatment.
  • Be in good general health, with a performance status score of 0 to 2.
  • Be 18 years or older.
  • Agree to participate in a related laboratory study.
  • Have adequate organ and bone marrow function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study. Men must also agree to use contraception.

Exclusion Criteria

  • Have had another cancer in the past 2 years, except for certain skin or cervical cancers.
  • Currently receiving or have recently received other cancer treatments.
  • Have ongoing side effects from previous treatments that could interfere with the study.
  • Have had major surgery or a significant injury recently.
  • Have organ transplants.
  • Have certain autoimmune diseases or conditions.
  • Have a history of HIV or active hepatitis B or C.
  • Have any medical condition that could make the study drugs unsafe or obscure side effects.
  • Have active COVID-19 or have had it recently without full recovery.
  • Have received certain immune therapies before.
  • Are on high doses of steroids or other immune-suppressing drugs.
  • Have certain heart conditions or severe uncontrolled medical issues.
  • Are pregnant, breastfeeding, or not using effective birth control if of reproductive potential.
  • Cannot comply with study appointments and procedures.

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