Participant flow

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.

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

   FG000

   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

   FG001

   title

   Arm B: Nivolumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         107

      2. group Id

         FG001

         num Subjects

         118

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         9

      type

      Participant Withdrew Consent

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Other reasons

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Not reported

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         355

      2. group Id

         FG001

         num Subjects

         359

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         237

      2. group Id

         FG001

         num Subjects

         227

      comment

      Continuing in the study

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         132

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

714 Participants were randomized and received study treatment

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Preserved source evidence · Not medical advice