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Phase II Trial of Belzutifan or Pembrolizumab for Clear Cell Kidney Cancer

This study is testing if belzutifan alone, pembrolizumab alone, or a combination of both drugs can help control clear cell renal cell carcinoma (a type of kidney cancer) before surgery. These drugs are given before a total or partial nephrectomy (surgery to remove all or part of a kidney). You may be able to join if you are 18 or older and have clear cell renal cell carcinoma confirmed by a biopsy. The study will look at how many patients respond to the treatment (tumor shrinkage) or have a good pathologic response (little cancer remaining after surgery). The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is a Phase II trial, meaning it's an early-stage study to see if a new treatment is effective and safe.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07187778

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~10 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:PembrolizumabBelzutifan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1. Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Clear Cell Renal Cell Carcinoma

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Clear Cell Renal Cell Carcinoma

NCT07187778

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Eric Jonasch, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Eric Jonasch, MD
[email protected]
(713) 563-7232
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Biopsy or archival tissue proven clear cell renal cell carcinoma (ccRCC).
Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading:
NOTE: Fuhrman Tumor Grade and/or WHO/ISUP Tumor Grade are required for all subjects entering the study.
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Has any of the following:
Diagnosis of immunodeficiency, active autoimmune disease (per Investigator's discretion), history of pneumonitis, active infection, or known additional malignancy other than RCC.
Has a known history of HIV infection. Note: Testing for HIV at screening is only required if mandated by local health authority.
Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \[qualitative\] is detected) infection.
Pregnant or breastfeeding women are excluded from this study because pembrolizumab is a Class-D agent with the potential for teratogenic or abortifacient effects and belzutifan has shown embryofetal toxicity in nonclinical studies
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has any known metastatic disease that is not planned to undergo surgical resection at the time of surgery (with the exception of ipsilateral adrenal metastases that are resectable at surgery).
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.
Has moderate to severe hepatic impairment (Child-Pugh B or C).
Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
Has received prior treatment with belzutifan or another HIF-2α inhibitor.
Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.

What this trial measures

  • 1. Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0