Participant flow

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma · Source last updated 2011-07-11

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

groups

1. description

   Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

   id

   FG000

   title

   Ipilimumab Plus gp100

2. description

   Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

   id

   FG001

   title

   Ipilimumab Monotherapy

3. description

   Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

   id

   FG002

   title

   gp100

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         306

      2. group Id

         FG001

         num Subjects

         100

      3. group Id

         FG002

         num Subjects

         119

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      type

      Subject Withdrew Consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Protocol Violation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         403

      2. group Id

         FG001

         num Subjects

         137

      3. group Id

         FG002

         num Subjects

         136

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         381

      2. group Id

         FG001

         num Subjects

         131

      3. group Id

         FG002

         num Subjects

         131

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         82

      2. group Id

         FG001

         num Subjects

         31

      3. group Id

         FG002

         num Subjects

         10

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         321

      2. group Id

         FG001

         num Subjects

         106

      3. group Id

         FG002

         num Subjects

         126

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the 1783 participants who enrolled and were screened for study participation, a total of 676 subjects were randomized.

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Preserved source evidence · Not medical advice