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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07187778
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Oral administration
  • Belzutifan — DRUG
    Oral administration

Study Details

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.

Key Dates

Start date
Dec 19, 2025
Status verified
Jan 2026
Primary completion
Jul 19, 2027
Completion
Jul 19, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combo-B+P: Phase II Combo Neoadjuvant Treatment with Belzutifan (PO/QD) and Pembrolizumab (IV Q3W)
    Participants will undergo evaluations at baseline, 3 weeks, 6 weeks, 9 weeks, and 12 weeks after initiation of treatment
  • Experimental: Mono-B: Phase II Mono Neoadjuvant Treatment with Belzutifan (PO/QD)
    Participants will undergo evaluations at baseline, 3 weeks, 6 weeks, 9 weeks, and 12 weeks after initiation of treatment
  • Experimental: Mono-P: Phase II Mono Neoadjuvant Treatment with Pembrolizumab (IV Q3W)
    Participants will undergo evaluations at baseline, 3 weeks, 6 weeks, 9 weeks, and 12 weeks after initiation of treatment

Primary Outcome Measure

1. Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Eric Jonasch, MD
[email protected]
713-563-7232
Eric Jonasch, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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