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NCT03470922 · OUTCOME

The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

What was measured

The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.

Analysis population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter

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 + Nivolumab342
Arm B: Nivolumab345

Reported measurements

ALT OR AST > 3XULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab26Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab15Not reportedNot reportedNot reportedNot reported
ALT OR AST> 5XULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab11Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab7Not reportedNot reportedNot reportedNot reported
ALT OR AST> 10XULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab4Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab4Not reportedNot reportedNot reportedNot reported
ALT OR AST > 20XULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab0Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab2Not reportedNot reportedNot reportedNot reported
TOTAL BILIRUBIN > 2XULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab2Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab5Not reportedNot reportedNot reportedNot reported
ALP > 1.5xULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab339
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab34Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab30Not reportedNot reportedNot reportedNot reported
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab2Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab2Not reportedNot reportedNot reportedNot reported
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYS

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab2Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab2Not reportedNot reportedNot reportedNot reported
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab2Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab1Not reportedNot reportedNot reportedNot reported
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab342
Arm B: Nivolumab345
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab2Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT OR AST > 3XULN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT OR AST> 5XULN
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT OR AST> 10XULN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT OR AST > 20XULN
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    TOTAL BILIRUBIN > 2XULN
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        30
    denoms
    1. counts
      1. group Id
        OG000
        value
        339
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALP > 1.5xULN
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYS
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        342
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
denoms
  1. counts
    1. group Id
      OG000
      value
      342
    2. group Id
      OG001
      value
      345
    units
    Participants
description
The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.
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
COUNT_OF_PARTICIPANTS
population Description
All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter
reporting Status
POSTED
time Frame
From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
title
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice