Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01721746 · OUTCOME

Progression Free Survival (PFS)

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037) · Source last updated 2022-04-19

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 the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)

What was measured

Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab

Nivolumab 3 mg/kg IV over 60 minutes Q2W

Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W

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

Analysis denominator · Participants

GroupSource count
Nivolumab272
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)133

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab3.12Not reported2.333.52Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)3.65Not reported2.305.29Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.1
    ci Upper Limit
    1.36
    estimate Comment
    Stratified Cox proportional hazard model.
    group Description
    Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.03
Complete source fields
analyses
  1. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.1
    ci Upper Limit
    1.36
    estimate Comment
    Stratified Cox proportional hazard model.
    group Description
    Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.03
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.33
        upper Limit
        3.52
        value
        3.12
      2. group Id
        OG001
        lower Limit
        2.30
        upper Limit
        5.29
        value
        3.65
denoms
  1. counts
    1. group Id
      OG000
      value
      272
    2. group Id
      OG001
      value
      133
    units
    Participants
description
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    id
    OG000
    title
    Nivolumab
  2. description
    Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
    id
    OG001
    title
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice