Trial · NCT04489771

A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)

NCT04489771, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2024-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013). Trials, record NCT04489771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04489771

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
NCT number: NCT04489771
Status: Completed
Phases: Phase 2
Enrollment: 154 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Carcinoma, Renal Cell
Interventions: Belzutifan
First posted: 2020-07-28
Last updated: 2026-09-24
Other registries' IDs: eudract:2020-001907-18
Results first posted: 2024-02-28

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	Up to approximately 27 months	ORR was defined as the percentage of participants who had a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Secondary	Progression-Free Survival (PFS) According to RECIST 1.1 as Assessed by BICR	Up to approximately 27 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by blinded independent central review was presented.
Secondary	Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	Up to approximately 27 months	For participants who demonstrated a confirmed complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR as assessed by blinded independent central review was presented.
Secondary	Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR	Up to approximately 27 months	CBR is defined as the percentage of participants who have a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD: Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) ≥6 months per RECIST 1.1. The percentage of participants with CBR will be presented.
Secondary	Overall Survival (OS)	Up to approximately 27 months	OS was defined as the time from randomization to death due to any cause.
Secondary	Number of Participants Who Experience One or More Adverse Events (AEs)	Up to approximately 27 months	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs was presented.
Secondary	Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 26 months	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE was presented.
Secondary	Maximum Plasma Concentration (Cmax) of Belzutifan	Weeks 1 and 3 on Day 1: predose and 1, 2, and 4 hours. Week 5 on Day 1: predose only	Blood samples were obtained at designated time points for the determination of the Cmax of belzutifan.
Secondary	Trough Plasma Concentration (Ctrough) of Belzutifan	Weeks 1 and 3 on Day 1: predose and 1, 2, and 4 hours. Week 5 on Day 1: predose only	Blood samples were obtained at designated time points for the determination of the Ctrough of belzutifan.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	Up to approximately 27 months	The analysis population consisted of all randomized participants based on the treatment group to which they were randomized.	Percentage of Participants	NUMBER
SECONDARY	Progression-Free Survival (PFS) According to RECIST 1.1 as Assessed by BICR	Up to approximately 27 months	The analysis population consisted of all randomized participants based on the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	Up to approximately 27 months	The analysis population consisted of all randomized participants based on the treatment group to which they were randomized who experienced a confirmed CR or PR.	Months	MEDIAN
SECONDARY	Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR	Up to approximately 27 months	The analysis population consisted of all randomized participants based on the treatment group to which they were randomized.	Percentage of Participants	NUMBER
SECONDARY	Overall Survival (OS)	Up to approximately 27 months	The analysis population consisted of all randomized participants based on the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	Number of Participants Who Experience One or More Adverse Events (AEs)	Up to approximately 27 months	All randomized participants who received at least one dose of study treatment.	Number of Participants	NUMBER
SECONDARY	Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 26 months	All randomized participants who received at least one dose of study treatment.	Number of Participants	NUMBER
SECONDARY	Maximum Plasma Concentration (Cmax) of Belzutifan	Weeks 1 and 3 on Day 1: predose and 1, 2, and 4 hours. Week 5 on Day 1: predose only	The analysis population consisted of all randomized participants based on the treatment group to which they were randomized who had at least 1 measurable belzutifan concentration observation.	ng/mL	GEOMETRIC_MEAN
SECONDARY	Trough Plasma Concentration (Ctrough) of Belzutifan	Weeks 1 and 3 on Day 1: predose and 1, 2, and 4 hours. Week 5 on Day 1: predose only	The analysis population consisted of all randomized participants based on the treatment group to which they were randomized who had at least 1 measurable belzutifan concentration observation.	ng/mL	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	Belzutifan 200 mg	23.1	95% Confidence Interval 14.3 to 34.0	Percentage of Participants
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	Belzutifan 120 mg	23.7	95% Confidence Interval 14.7 to 34.8	Percentage of Participants
Progression-Free Survival (PFS) According to RECIST 1.1 as Assessed by BICR	Belzutifan 200 mg	9.1	95% Confidence Interval 5.5 to 12.0	Months
Progression-Free Survival (PFS) According to RECIST 1.1 as Assessed by BICR	Belzutifan 120 mg	7.3	95% Confidence Interval 5.6 to 9.5	Months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	Belzutifan 200 mg	16.1	95% Confidence Interval 6.5 to NA	Months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	Belzutifan 120 mg	NA	95% Confidence Interval 3.8 to NA	Months
Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR	Belzutifan 200 mg	41.0	95% Confidence Interval 30.0 to 52.7	Percentage of Participants
Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR	Belzutifan 120 mg	47.4	95% Confidence Interval 35.8 to 59.2	Percentage of Participants
Overall Survival (OS)	Belzutifan 200 mg	NA	95% Confidence Interval 20.6 to NA	Months
Overall Survival (OS)	Belzutifan 120 mg	NA	95% Confidence Interval 22.0 to NA	Months

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Belzutifan 200 mg	78
Overall Study	STARTED	Belzutifan 120 mg	76
Overall Study	COMPLETED	Belzutifan 200 mg	0
Overall Study	COMPLETED	Belzutifan 120 mg	0
Overall Study	NOT COMPLETED	Belzutifan 200 mg	78
Overall Study	NOT COMPLETED	Belzutifan 120 mg	76

Source ClinicalTrials.gov

Adverse events262

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Belzutifan 200 mg	64	78	71
other	Anaemia	Blood and lymphatic system disorders	Belzutifan 120 mg	58	76	77
other	Lymphopenia	Blood and lymphatic system disorders	Belzutifan 200 mg	3	78	3
other	Lymphopenia	Blood and lymphatic system disorders	Belzutifan 120 mg	4	76	4
other	Vision blurred	Eye disorders	Belzutifan 200 mg	4	78	4
other	Vision blurred	Eye disorders	Belzutifan 120 mg	2	76	2
other	Abdominal pain	Gastrointestinal disorders	Belzutifan 200 mg	6	78	7
other	Abdominal pain	Gastrointestinal disorders	Belzutifan 120 mg	9	76	12
other	Constipation	Gastrointestinal disorders	Belzutifan 200 mg	8	78	10
other	Constipation	Gastrointestinal disorders	Belzutifan 120 mg	15	76	18

1 to 10 of 262Source ClinicalTrials.gov

See all 262 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Belzutifan 200 mg	28	78
Total, all-cause mortality	Belzutifan 120 mg	25	76
Total, other adverse events	Belzutifan 200 mg	75	78
Total, other adverse events	Belzutifan 120 mg	74	76
Total, serious adverse events	Belzutifan 200 mg	33	78
Total, serious adverse events	Belzutifan 120 mg	33	76

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39233312	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Belzutifan 200 mg vs Belzutifan 120 mg: deaths from any cause	Trial comparisons
Belzutifan 200 mg vs Belzutifan 120 mg: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04489771

GET https://conductscience.org/api/trials/v1/NCT04489771/events?page=2

API reference For AI assistants