OncoMatch/Clinical Trials/NCT07187778
Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)
Is NCT07187778 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Belzutifan for clear cell renal cell carcinoma.
Treatment: Pembrolizumab · Belzutifan — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage PT2, PT3, PT4 (pathological TNM)
Grade: Grade 4any grade (Fuhrman and/or WHO/ISUP)
Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading
Performance status
ZUBROD/ECOG 0–1
Prior therapy
Cannot have received: chemotherapy
Patients who have had chemotherapy or radiotherapy for RCC prior to study.
Cannot have received: radiation therapy
Patients who have had chemotherapy or radiotherapy for RCC prior to study.
Cannot have received: anti-PD-1 therapy
Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4
Cannot have received: anti-PD-L1 therapy
Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4
Cannot have received: anti-PD-L2 therapy
Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4
Cannot have received: anti-CTLA-4 therapy
Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4
Cannot have received: colony-stimulating factors (G-CSF, GM-CSF, recombinant EPO)
Exception: ≤28 days prior to the first dose of study intervention
received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) ≤28 days prior to the first dose of study intervention
Cannot have received: HIF-2A inhibitor (belzutifan)
Has received prior treatment with belzutifan or another HIF-2α inhibitor.
Lab requirements
Blood counts
ANC ≥1000, PLT ≥ 75, Hgb ≥9 (transfusion allowed if Hgb < 1.5 or = to upper limit of normal)
Liver function
Has moderate to severe hepatic impairment (Child-Pugh B or C) [excluded]
Cardiac function
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. 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 [excluded]. Medically controlled arrhythmia stable on medication is permitted.
Screening laboratory criteria include the following: a. ANC ≥1000, PLT ≥ 75, Hgb ≥9 (transfusion allowed if Hgb < 1.5 or = to upper limit of normal). Has moderate to severe hepatic impairment (Child-Pugh B or C) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07187778 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage PT2 or PT3 or PT4 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages