Participant flow

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma · Source last updated 2026-03-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.

   id

   FG000

   title

   Tebentafusp

2. description

   Dacarbazine administered at 1,000 mg/m\^2 of body surface area IV infusion every 3 weeks until confirmed disease progression or unacceptable toxicity.

   id

   FG001

   title

   Investigator's Choice: Dacarbazine

3. description

   Ipilimumab administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments.

   id

   FG002

   title

   Investigator's Choice: Ipilimumab

4. description

   Pembrolizumab administered at 2 mg/kg IV infusion over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.

   id

   FG003

   title

   Investigator's Choice: Pembrolizumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         12

      type

      Not Treated

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         3

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         154

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         70

      type

      Progressive Disease

   6. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         3

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Alternate anticancer treatment

   8. reasons

      1. group Id

         FG000

         num Subjects

         73

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         11

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         252

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         16

      4. group Id

         FG003

         num Subjects

         103

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         252

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         103

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The data cut-off date for this analysis was 13 October 2020. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design.

recruitment Details

A total of 378 patients were randomly assigned (2:1) to Tebentafusp (n=252) or Investigator's Choice (n=126) at 58 sites in 14 countries.

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

Preserved source evidence · Not medical advice