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NCT03470922 · OUTCOME

Progression Free Survival (PFS)

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma · Source last updated 2025-09-09

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 to date of first documented tumor progression or death (up to approximately 33 months)

What was measured

Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

Analysis population: All randomized participants

Groups in this outcome

Arm A: Relatlimab + Nivolumab

Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.

Arm B: Nivolumab

Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.

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

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab355
Arm B: Nivolumab359

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab10.12Not reported6.3715.74Not reported
Arm B: Nivolumab4.63Not reported3.385.62Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0055
    param Type
    Cox Proportional Hazard
    param Value
    0.75
    statistical Comment
    Log-rank test stratified by LAG-3 (≥ 1% vs \< 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any\[0\] vs M1any\[1\])
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0055
    param Type
    Cox Proportional Hazard
    param Value
    0.75
    statistical Comment
    Log-rank test stratified by LAG-3 (≥ 1% vs \< 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any\[0\] vs M1any\[1\])
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.37
        upper Limit
        15.74
        value
        10.12
      2. group Id
        OG001
        lower Limit
        3.38
        upper Limit
        5.62
        value
        4.63
denoms
  1. counts
    1. group Id
      OG000
      value
      355
    2. group Id
      OG001
      value
      359
    units
    Participants
description
Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.
    id
    OG000
    title
    Arm A: Relatlimab + Nivolumab
  2. description
    Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
    id
    OG001
    title
    Arm B: Nivolumab
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to date of first documented tumor progression or death (up to approximately 33 months)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice