Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03470922 · OUTCOME

The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid 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 thyroid 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 + Nivolumab328
Arm B: Nivolumab333

Reported measurements

TSH > ULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab328
Arm B: Nivolumab333
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab106Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab106Not reportedNot reportedNot reportedNot reported
TSH > ULN WITH TSH <= ULN AT BASELINE

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab327
Arm B: Nivolumab331
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab84Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab82Not reportedNot reportedNot reportedNot reported
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab318
Arm B: Nivolumab322
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab63Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab48Not reportedNot reportedNot reportedNot reported
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab318
Arm B: Nivolumab322
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab7Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab7Not reportedNot reportedNot reportedNot reported
TSH > ULN WITH FT3/FT4 TEST MISSING

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab318
Arm B: Nivolumab322
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab8Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab9Not reportedNot reportedNot reportedNot reported
TSH < LLN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab328
Arm B: Nivolumab333
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab89Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab84Not reportedNot reportedNot reportedNot reported
TSH <LLN WITH TSH >= LLN AT BASELINE

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab327
Arm B: Nivolumab331
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab79Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab78Not reportedNot reportedNot reportedNot reported
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab318
Arm B: Nivolumab322
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab51Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab40Not reportedNot reportedNot reportedNot reported
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab318
Arm B: Nivolumab322
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab6Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab3Not reportedNot reportedNot reportedNot reported
TSH < LLN WITH FT3/FT4 TEST MISSING

Analysis denominator · Participants

GroupSource count
Arm A: Relatlimab + Nivolumab318
Arm B: Nivolumab322
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Relatlimab + Nivolumab11Not reportedNot reportedNot reportedNot reported
Arm B: Nivolumab7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        106
    denoms
    1. counts
      1. group Id
        OG000
        value
        328
      2. group Id
        OG001
        value
        333
      units
      Participants
    title
    TSH > ULN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        82
    denoms
    1. counts
      1. group Id
        OG000
        value
        327
      2. group Id
        OG001
        value
        331
      units
      Participants
    title
    TSH > ULN WITH TSH <= ULN AT BASELINE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        48
    denoms
    1. counts
      1. group Id
        OG000
        value
        318
      2. group Id
        OG001
        value
        322
      units
      Participants
    title
    TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        318
      2. group Id
        OG001
        value
        322
      units
      Participants
    title
    TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        318
      2. group Id
        OG001
        value
        322
      units
      Participants
    title
    TSH > ULN WITH FT3/FT4 TEST MISSING
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        84
    denoms
    1. counts
      1. group Id
        OG000
        value
        328
      2. group Id
        OG001
        value
        333
      units
      Participants
    title
    TSH < LLN
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        78
    denoms
    1. counts
      1. group Id
        OG000
        value
        327
      2. group Id
        OG001
        value
        331
      units
      Participants
    title
    TSH <LLN WITH TSH >= LLN AT BASELINE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        40
    denoms
    1. counts
      1. group Id
        OG000
        value
        318
      2. group Id
        OG001
        value
        322
      units
      Participants
    title
    TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        318
      2. group Id
        OG001
        value
        322
      units
      Participants
    title
    TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        318
      2. group Id
        OG001
        value
        322
      units
      Participants
    title
    TSH < LLN WITH FT3/FT4 TEST MISSING
denoms
  1. counts
    1. group Id
      OG000
      value
      328
    2. group Id
      OG001
      value
      333
    units
    Participants
description
The number of participants with clinical laboratory test abnormalities in specific thyroid 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 Thyroid Tests
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice