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NCT01668784 · OUTCOME

Extended Collection to Post Hoc Overall Survival (OS)

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025) · Source last updated 2022-08-09

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
from randomization up to disease progression or death (approximately up to 105 months)

What was measured

Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p \< 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria. This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.

Analysis population: All Randomized Participants

Groups in this outcome

Nivolumab

Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

Everolimus

Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

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

Analysis denominator · Participants

GroupSource count
Nivolumab410
Everolimus411

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab25.82Not reported22.2129.77Not reported
Everolimus19.55Not reported17.6421.88Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Stratified Cox Proportional hazard Model
    param Value
    0.74
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Stratified Cox Proportional hazard Model
    param Value
    0.74
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.21
        upper Limit
        29.77
        value
        25.82
      2. group Id
        OG001
        lower Limit
        17.64
        upper Limit
        21.88
        value
        19.55
denoms
  1. counts
    1. group Id
      OG000
      value
      410
    2. group Id
      OG001
      value
      411
    units
    Participants
description
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p \< 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria. This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    OG000
    title
    Nivolumab
  2. description
    Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    OG001
    title
    Everolimus
param Type
MEDIAN
population Description
All Randomized Participants
reporting Status
POSTED
time Frame
from randomization up to disease progression or death (approximately up to 105 months)
title
Extended Collection to Post Hoc Overall Survival (OS)
type
POST_HOC
unit Of Measure
Months

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

Preserved source evidence · Not medical advice