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belzutifan

Generic: BELZUTIFAN·Brand: WELIREG, Welireg

belzutifan: 17 clinical trials tracked.

belzutifan evidence translation

What we can confirm

17 tracked trials

No verified listed developer

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about belzutifan, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 1 study sponsors
Clinical Trials (17)showing 10 most recent

LIGHTBEAM-U01 Substudy 01E: A Phase 2 Substudy to Evaluate the Safety and Efficacy of Belzutifan in Participants With Solid Tumors

NCT07700758·Phase 2
Not yet recruiting

Primary endpoint: Number of Participants Who Experience One or More Adverse Events (AEs)

Interventionalopen15 targetStarted 2026-11Completion 2034-01Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)

NCT07489495·Phase 3
Recruiting

Primary endpoint: Progression-free Survival (PFS)

InterventionalRandomizedtriple758 targetStarted 2026-04Completion 2030-1150 sites · Argentina, Australia, Brazil, Chile…Merck Sharp & Dohme LLC

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

NCT07405164·Phase 3
Recruiting

Primary endpoint: Cohort A and Cohort B: Overall Survival (OS)

Interventionalopen450 targetStarted 2026-03Completion 2034-0150 sites · Australia, Belgium, Brazil, Canada…Merck Sharp & Dohme LLC

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

NCT07187778·Phase 2
Recruiting

Primary endpoint: 1. Safety and Adverse Events (AEs)

Interventionalopen10 targetStarted 2025-12Completion 2029-071 site · United StatesM.D. Anderson Cancer Center

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

NCT07227402·Phase 3
Recruiting

Primary endpoint: Progression Free Survival (PFS)

InterventionalRandomizedopen904 targetStarted 2025-11Completion 2032-0250 sites · Argentina, Australia, Austria, Belgium…Merck Sharp & Dohme LLC

Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)

NCT07023432·Phase 2
Recruiting

Primary endpoint: Safety and adverse events (AEs)

InterventionalRandomizedopen78 targetStarted 2025-11Completion 2030-041 site · United StatesM.D. Anderson Cancer Center

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy

NCT07049926·Phase 1/Phase 2
Recruiting

Primary endpoint: Safety Lead In Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)

Interventionalsingle140 targetStarted 2025-07Completion 2031-1030 sites · Chile, France, Israel, Poland…Merck Sharp & Dohme LLC

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)

NCT06428396·Phase 2
Active, not recruiting

Primary endpoint: Progression-free Survival (PFS)

InterventionalRandomizedopen120 targetStarted 2024-11Completion 2028-1241 sites · Argentina, Canada, Chile, Colombia…Merck Sharp & Dohme LLC

A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma

NCT05468697·Phase 1/Phase 2
Active, not recruiting

Primary endpoint: Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)

InterventionalRandomizedopen60 targetStarted 2022-08Completion 2026-1013 sites · Australia, Israel, United StatesMerck Sharp & Dohme LLC

An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

NCT05899049·Phase 3
Active, not recruiting

Primary endpoint: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

InterventionalRandomizedopen251 enrolledStarted 2022-07Completion 2027-0417 sites · ChinaMerck Sharp & Dohme LLC