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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502122-41-00

Acronym

MK-6482-012

Enrollment

491

Registered

2023-08-25

Start date

2021-05-11

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Clear cell renal cancer

Brief summary

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), Overall Survival (OS)

Detailed description

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR, Number of Participants Who Experienced At least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUGBelzutifan

DRUGLenvatinib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGMK-1308A

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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), Overall Survival (OS)	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR, Number of Participants Who Experienced At least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE	—

Countries

Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Norway, Poland, Romania, Spain, Sweden

Outcome results

None listed

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