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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504963-17-00

Acronym

MK-6482-024

Enrollment

Registered

2024-07-01

Start date

Unknown

Completion date

2025-06-13

Last updated

2025-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced ccRCC

Brief summary

Part 1 - Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT), Part 1 - Number of Participants Who Experience at Least One Adverse Event (AE), Part 1 - Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 - Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator

Detailed description

Part 2 - Clinical Benefit Rate (CBR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator, Part 2 - Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator, Part 2 - Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator, Part 2 - Overall Survival (OS), Part 2 - Number of Participants Who Experience at Least One Adverse Event (AE), Part 2 - Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUGBelzutifan

DRUGPALBOCICLIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1 - Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT), Part 1 - Number of Participants Who Experience at Least One Adverse Event (AE), Part 1 - Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 - Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator	—

Secondary

Measure	Time frame
Part 2 - Clinical Benefit Rate (CBR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator, Part 2 - Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator, Part 2 - Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator, Part 2 - Overall Survival (OS), Part 2 - Number of Participants Who Experience at Least One Adverse Event (AE), Part 2 - Number of Participants Who Discontinue Study Treatment Due to an AE	—

Measure

Time frame

—

Countries

France, Germany, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026