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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Biopsy proven clear cell renal cell carcinoma (ccRCC).

pT2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0

pT3 (presence of tumor thrombus, perinephric and/or sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC*

pT4, any g.rade, N0, M0

Disqualifiers

A pulse oximeter reading <92% at rest, or

Requires intermittent supplemental oxygen, or

Requires chronic supplemental oxygen

Diagnosis of immunodeficiency, active autoimmune disease (per Investigator's discretion), history of pneumonitis, active infection, or known additional malignancy other than RCC.

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Belzutifan

Treatment groups

10 Participants
are divided into 3 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator