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NCT04195750 · OUTCOME

Overall Survival (OS)

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) · Source last updated 2026-05-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 49 months

What was measured

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.

Analysis population: 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.

Groups in this outcome

Belzutifan

Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.

Everolimus

Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Belzutifan374
Everolimus372

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Belzutifan21.4Not reported18.224.3Not reported
Everolimus18.2Not reported15.821.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    estimate Comment
    Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.17644
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
    statistical Comment
    One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    estimate Comment
    Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.17644
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
    statistical Comment
    One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.2
        upper Limit
        24.3
        value
        21.4
      2. group Id
        OG001
        lower Limit
        15.8
        upper Limit
        21.8
        value
        18.2
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      372
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.
    id
    OG000
    title
    Belzutifan
  2. description
    Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.
    id
    OG001
    title
    Everolimus
param Type
MEDIAN
population Description
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.
reporting Status
POSTED
time Frame
Up to approximately 49 months
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice