Study on Seleno-L Methionine, Axitinib, and Pembrolizumab for Advanced Kidney Cancer

Sponsor: Bilal G. Rahim

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05363631

Provider View

This clinical trial is testing the safety and effectiveness of adding Seleno-L Methionine to the standard treatment of Axitinib and Pembrolizumab for patients with advanced kidney cancer that has spread or cannot be removed by surgery.

Patient Parameters

Program Overview

The study aims to find out if adding Seleno-L Methionine (SLM) to the usual treatment of Axitinib and Pembrolizumab can improve outcomes for patients with advanced clear cell renal cell carcinoma (ccRCC). The trial is divided into two parts: the first part will determine the safest dose of SLM, and the second part will test its effectiveness at that dose.

Description

This study is a Phase I/II trial, meaning it will first focus on finding the safest dose of Seleno-L Methionine (SLM) to use with Axitinib and Pembrolizumab, and then assess how well this combination works in treating advanced kidney cancer. The trial is open-label, so both the researchers and participants will know which treatments are being given.

In the first part of the study, researchers will gradually increase the dose of SLM to find the maximum amount that can be given safely. Once this dose is determined, the second part of the study will begin, where the effectiveness of the treatment will be evaluated.

Participants in this study will be those who have not received prior treatment for their advanced kidney cancer, except for certain immunotherapy treatments given after surgery. The study will monitor the safety and potential benefits of adding SLM to the standard treatment regimen.

Eligibility Criteria

Inclusion Criteria

  • Must provide written and voluntary consent to participate.
  • Have a confirmed diagnosis of locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) that cannot be surgically removed.
  • Must not have received prior treatment for metastatic cancer, except for certain immunotherapy treatments after surgery.
  • Be 18 years or older.
  • Have at least one tumor that can be measured and has not been treated with radiation.
  • Be in good overall health, able to perform daily activities with minimal restrictions.
  • Have normal kidney function or slightly reduced function as measured by specific tests.
  • Have normal liver function or slightly elevated levels if cancer has spread to the liver.
  • Have adequate blood cell counts, including neutrophils, platelets, and hemoglobin.
  • Have controlled blood pressure, with or without medication.
  • Women of childbearing potential and men who are sexually active must agree to use effective contraception during the study and for six months after treatment.

Exclusion Criteria

  • Have another type of cancer that could interfere with the study.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Be pregnant or breastfeeding.
  • Be taking or need to take certain medications that affect liver enzymes.
  • Have had a heart attack, severe chest pain, heart failure, or stroke in the past six months.
  • Have had major surgery within four weeks before starting the study.
  • Have HIV with low CD4+ T-cell counts or a history of AIDS-related infections.
  • No exclusions based on sex, race, or ethnic background.

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