A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505023-31-00

Acronym

MK-6482-022

Enrollment

549

Registered

2023-10-31

Start date

2023-11-17

Completion date

Unknown

Last updated

2025-09-10

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

Conditions

Renal cell carcinoma

Brief summary

Disease-Free Survival (DFS)

Detailed description

Overall Survival (OS), Number of Participants Who Experience At Least One Adverse event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Disease Recurrence-Specific Survival 1 (DRSS1), Disease Recurrence-Specific Survival 2 (DRSS2), Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score, Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score, Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGBelzutifan

DRUGPlacebo for MK6482

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival (DFS)	—

Secondary

Measure	Time frame
Overall Survival (OS), Number of Participants Who Experience At Least One Adverse event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Disease Recurrence-Specific Survival 1 (DRSS1), Disease Recurrence-Specific Survival 2 (DRSS2), Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score, Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score, Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score	—

Measure

Time frame

—

Countries

Bulgaria, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Romania, Spain, Sweden

Outcome results

None listed

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