Study on Immune and Targeted Combination Therapies for First Line Renal Cell Carcinoma

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04626479

Provider View

This clinical trial is exploring new combinations of treatments for patients with advanced renal cell carcinoma (RCC) who have not received prior treatment for their advanced cancer. The study aims to assess the safety and effectiveness of these experimental therapies.

Patient Parameters

Program Overview

This study is part of a larger research project focused on testing new treatments for renal cell carcinoma (RCC), a type of kidney cancer. The specific goal of this part of the study is to evaluate how safe and effective new combinations of experimental drugs are for patients with advanced clear cell renal cell carcinoma (ccRCC) who are receiving their first treatment for advanced cancer. The study will be conducted in two phases: the first phase will focus on ensuring the treatments are safe, and the second phase will evaluate how well they work.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced clear cell renal cell carcinoma (ccRCC).
  • Have not received any prior treatment for advanced RCC, except for certain therapies completed over a year ago.
  • Able to swallow pills.
  • Have good organ function.
  • If receiving bone-strengthening therapy, it must have started at least two weeks before joining the study.
  • Any side effects from previous treatments must be mild or resolved.
  • Blood pressure must be controlled and stable.
  • Male participants must agree to use contraception or abstain from sex during and shortly after treatment.
  • Female participants must not be pregnant, must use contraception or abstain from sex during and after treatment, and must not breastfeed during and after the study.

Exclusion Criteria

  • Have high levels of protein in urine or need oxygen support.
  • Have had significant heart problems in the past year.
  • Have had major surgery within three weeks before starting the study.
  • Have a history of lung disease or inflammatory bowel disease.
  • Have digestive issues that affect absorption or have had certain surgeries.
  • Have received radiation therapy recently.
  • Have had a live vaccine recently.
  • Have had more than four previous cancer treatments.
  • Have immune system deficiencies or are on immunosuppressive therapy.
  • Have another active cancer or brain metastases.
  • Have an autoimmune disease needing treatment in the past two years.
  • Have an active infection needing treatment.
  • Have a history of HIV or Hepatitis B.
  • Have had a tissue or organ transplant.

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