Phase II Study of Belzutifan or Pembrolizumab Alone Versus Combined as Pre-Surgery Treatment for Clear Cell Kidney Cancer (BLAZE)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07187778

Provider View

This clinical trial is exploring whether using belzutifan alone, pembrolizumab alone, or both together before kidney surgery can help control advanced clear cell kidney cancer.

Patient Parameters

Program Overview

The study aims to find out if belzutifan, pembrolizumab, or their combination, given before surgery to remove part or all of a kidney, can effectively manage locally advanced clear cell renal cell carcinoma (ccRCC).

Description

The main goal of this study is to see how well the treatments work in shrinking the cancer or reducing the amount of active cancer cells in the kidney tissue after 12 weeks of treatment. Researchers will also look at how long patients stay free from cancer returning, the safety of the treatments, and how they affect patients' quality of life.

Participants will be monitored for any side effects and will report on their well-being during the study. The study will use specific criteria to measure the cancer's response to the treatments and will involve regular check-ups and tests to track progress.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of clear cell renal cell carcinoma (ccRCC) through a biopsy.
  • Must have intermediate-high risk, high risk, or M1 ccRCC based on specific medical criteria.
  • Must be evaluated and approved for kidney surgery by a urologist.
  • Must be 18 years or older and agree to participate.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must not have distant metastases based on recent imaging tests.
  • Must meet specific blood test criteria for blood cell counts and organ function.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
  • Men must agree to use contraception or be abstinent during the study and for a specified period after treatment.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have a resting oxygen level below 92% or need supplemental oxygen.
  • Cannot have had previous chemotherapy or radiotherapy for kidney cancer.
  • Cannot be taking other experimental drugs.
  • Cannot have allergies to similar drugs used in the study.
  • Cannot have had certain immune therapies or growth factors recently.
  • Cannot have immune system deficiencies, active autoimmune diseases, or certain infections.
  • Cannot have a history of HIV, hepatitis B, or active hepatitis C.
  • Cannot be pregnant or breastfeeding.
  • Cannot have another progressing cancer or one that needed treatment in the last 3 years, except for certain skin cancers or other non-invasive cancers.
  • Cannot have significant heart disease or severe liver problems.
  • Cannot have digestive issues that affect medication absorption.
  • Cannot have taken belzutifan or similar drugs before.
  • Cannot be on certain medications that affect how the study drugs work.
  • Cannot have active infections requiring treatment or active tuberculosis.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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