NCT07187778

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objective: 1\. A composite primary endpoint of objective response rate (ORR) or pathologic response rate (PRR) at 12 weeks after neoadjuvant therapy. objective response - defined as partial \[≥ 30% decrease in largest diameter\] or complete response on imaging at 12 weeks after neoadjuvant therapy (according to Response Evaluation Criteria In Solid Tumors \[RECIST\] criteria) (Appendix 14.2) Pathologic response - defined as ≤25% residual viable tumor in post-therapy pathology specimen. Secondary Objectives: 1. Relapse-Free Survival (RFS) - defined as the length of time after randomization to date of radiographic/clinical progression, recurrence or death 2. Safety/Tolerability - including adverse events \[by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)\], laboratory results, vital signs, physical examinations 3. Quality of Life - as measured by patient-reported outcome measures, including EORTC-QLQ-C30 and FACT-G Single Item GP5 (Appendix 14.3, Appendix 14.4)

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Oral administration
DRUG	Belzutifan	Oral administration

Timeline

• Start date: 2025-12-19
• Primary completion: 2027-07-19
• Completion: 2029-07-19
• First posted: 2025-09-23
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study