Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07187778

Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)

Led by M.D. Anderson Cancer Center · Updated on 2026-01-05

10

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.

CONDITIONS

Official Title

Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy confirmed clear cell renal cell carcinoma (ccRCC)
  • Intermediate-high risk, high risk, or M1 ccRCC meeting specified tumor grading and staging
  • Approved by urology as candidates for nephrectomy
  • Age 18 years or older and able to consent
  • Performance status of 0-1 on Zubrod/ECOG scale
  • No distant metastases on recent chest, abdomen, and pelvis imaging
  • Prior or concurrent malignancy allowed if not interfering with study
  • Laboratory criteria: ANC 651000, PLT 6575, Hgb 659 (transfusion allowed if Hgb < 1.5 or within normal limits)
  • Cardiac function class 2B or better by NYHA classification
  • Women of child-bearing potential and men must agree to use effective contraception during and after study per protocol
  • Willingness and ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Pulse oximeter reading <92% at rest or requiring supplemental oxygen
  • Prior chemotherapy or radiotherapy for RCC
  • Use of other investigational agents
  • Allergic reactions to belzutifan, pembrolizumab, or similar agents
  • Prior treatment with anti-PD1, PD-L1, PD-L2, CTLA-4 agents or colony-stimulating factors within 28 days
  • Diagnosis of immunodeficiency, active autoimmune disease, pneumonitis, active infection, or additional malignancy other than RCC
  • Known HIV infection or active hepatitis B or C (as per local requirements)
  • Inability to meet study requirements
  • Pregnant or breastfeeding women
  • Additional malignancy progressing or treated within past 3 years (except certain treated skin cancers or cancers in remission)
  • Metastatic disease not planned for surgical removal except resectable ipsilateral adrenal metastases
  • Significant cardiac disease including unstable angina, recent myocardial infarction, or NYHA class III/IV heart failure
  • Moderate to severe liver impairment
  • Unable to swallow oral medications or gastrointestinal conditions affecting absorption
  • Prior treatment with belzutifan or other HIF-2B1 inhibitors
  • Current use of strong or moderate CYP3A4 inducers that cannot be stopped
  • Active infection requiring systemic therapy
  • Active tuberculosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

E

Eric Jonasch, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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