Trial · NCT04195750
A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
NCT04195750, Phase 3, Active not recruiting, Merck Sharp & Dohme LLC; results first posted 2025-04-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005). Trials, record NCT04195750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04195750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
- NCT number
- NCT04195750
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 755 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Belzutifan, Everolimus
- First posted
- 2019-12-12
- Last updated
- 2026-10-20
- Other registries' IDs
- eudract:2019-003444-72
- Results first posted
- 2025-04-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 39 months | PFS is 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 is 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 is also considered PD. PFS as assessed by blinded independent central review is presented here. |
| Primary | Overall Survival (OS) | Up to approximately 49 months | OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. |
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | Up to approximately 31 months | ORR 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) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 is presented here. |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Up to approximately 49 months | For participants who demonstrate 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 is 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 is presented here. The Median DOR was analyzed by the Kaplan-Meier method for censored data. |
| Secondary | Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 78 months | An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 78 months | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be presented. |
| Secondary | Time to True Deterioration (TTD) 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 Combined Score | Up to approximately 39 months | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. If the first deterioration is at the last PRO assessment timepoint at the time of analysis, then no confirmation is required. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score | Up to approximately 39 months | The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. If the first deterioration is at the last PRO assessment timepoint at the time of analysis, then no confirmation is required. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score | Up to approximately 39 months | The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. TTD was defined as the time to first onset of a ≥3-point decrease in symptom score from baseline with confirmation by the subsequent visit of a ≥3-point deterioration from baseline under right-censoring rule. If the first deterioration is at the last PRO assessment timepoint at the time of analysis, then no confirmation is required. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Change From Baseline to Week 17 in the HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score | Baseline (Day 1) and week 17 | The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a higher score indicating a better overall outcome. Change from baseline to Week 17 in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 39 months | Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 49 months | Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | Up to approximately 31 months | Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Up to approximately 49 months | Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized, and who experienced a confirmed complete response (CR) or partial response (PR). Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 78 months | |||
| SECONDARY | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 78 months | |||
| SECONDARY | Time to True Deterioration (TTD) 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 Combined Score | Up to approximately 39 months | Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for EORTC QLQ-C30 and have received at least one dose of the study intervention; and had data available for this TTD in HRQoL outcome using EORTC QLQ-C30. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Months | MEDIAN |
| SECONDARY | TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score | Up to approximately 39 months | Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for EORTC QLQ-C30 and have received at least one dose of the study intervention; and had data available for this TTD in physical functioning outcome using EORTC QLQ-C30. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Months | MEDIAN |
| SECONDARY | TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score | Up to approximately 39 months | Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for FKSI-DRS and have received at least one dose of the study intervention; and had data available for this TTD in disease symptoms outcome using FKSI-DRS. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Months | MEDIAN |
| SECONDARY | Change From Baseline to Week 17 in the HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score | Baseline (Day 1) and week 17 | Per protocol, the analysis population consisted of all randomized participants who have received at least one dose of the study intervention and had assessments available for EORTC QLQ-C30 at baseline or post-baseline up to Week 17; and had data available for this change from baseline in HRQoL outcome using EORTC QLQ-C30. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures. | Score on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Belzutifan | 5.6 | 95% Confidence Interval 3.8 to 6.5 | Months | |
| Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Everolimus | 5.6 | 95% Confidence Interval 4.8 to 5.8 | Months | |
| Overall Survival (OS) | Belzutifan | 21.4 | 95% Confidence Interval 18.2 to 24.3 | Months | |
| Overall Survival (OS) | Everolimus | 18.2 | 95% Confidence Interval 15.8 to 21.8 | Months | |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | Belzutifan | 21.9 | 95% Confidence Interval 17.8 to 26.5 | Percentage of Participants | |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | Everolimus | 3.5 | 95% Confidence Interval 1.9 to 5.9 | Percentage of Participants | |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Belzutifan | 19.3 | 95% Confidence Interval 14.0 to 28.6 | Months | |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Everolimus | 13.7 | 95% Confidence Interval 5.6 to 20.5 | Months | |
Time to True Deterioration (TTD) 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 Combined Score | Belzutifan | 19.35 | 95% Confidence Interval 11.89 to NA | Months | |
Time to True Deterioration (TTD) 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 Combined Score | Everolimus | 10.19 | 95% Confidence Interval 6.47 to 12.98 | Months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belzutifan | 374 | |
| Overall Study | STARTED | Everolimus | 372 | |
| Overall Study | STARTED | Safety Run-In | 9 | |
| Overall Study | Treated | Belzutifan | 372 | |
| Overall Study | Treated | Everolimus | 360 | |
| Overall Study | Treated | Safety Run-In | 9 | |
| Overall Study | COMPLETED | Belzutifan | 0 | |
| Overall Study | COMPLETED | Everolimus | 0 | |
| Overall Study | COMPLETED | Safety Run-In | 0 | |
| Overall Study | NOT COMPLETED | Belzutifan | 374 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events831
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 | 294 | 372 | 503 |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus | 200 | 360 | 272 |
| other | Anaemia | Blood and lymphatic system disorders | Safety Run-In | 8 | 9 | 10 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Belzutifan | 14 | 372 | 23 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus | 25 | 360 | 34 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Safety Run-In | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Belzutifan | 29 | 372 | 38 |
| other | Abdominal pain | Gastrointestinal disorders | Everolimus | 21 | 360 | 23 |
| other | Abdominal pain | Gastrointestinal disorders | Safety Run-In | 0 | 9 | 0 |
| other | Constipation | Gastrointestinal disorders | Belzutifan | 63 | 372 | 78 |
1 to 10 of 831Source ClinicalTrials.gov
See all 831 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belzutifan | 254 | 374 |
| Total, all-cause mortality | Everolimus | 259 | 372 |
| Total, all-cause mortality | Safety Run-In | 5 | 9 |
| Total, other adverse events | Belzutifan | 356 | 372 |
| Total, other adverse events | Everolimus | 348 | 360 |
| Total, other adverse events | Safety Run-In | 9 | 9 |
| Total, serious adverse events | Belzutifan | 160 | 372 |
| Total, serious adverse events | Everolimus | 139 | 360 |
| Total, serious adverse events | Safety Run-In | 4 | 9 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT04195750
GET https://conductscience.org/api/trials/v1/NCT04195750/results?page=2