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NCT01721746 · OUTCOME

Objective Response Rate (ORR)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)

What was measured

Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1

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 over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes 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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab27.2Not reported22.032.9Not reported
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)9.8Not reported5.316.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.0
        upper Limit
        32.9
        value
        27.2
      2. group Id
        OG001
        lower Limit
        5.3
        upper Limit
        16.1
        value
        9.8
denoms
  1. counts
    1. group Id
      OG000
      value
      272
    2. group Id
      OG001
      value
      133
    units
    Participants
description
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
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 over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
    id
    OG001
    title
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice