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NCT00094653 · OUTCOME

12-, 18-, and 24-Month Survival Rates

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.

Measure
NUMBER
Unit
probability
Interval / dispersion
95% Confidence Interval
Time frame
Month 12, Month 18, Month 24

What was measured

The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.

Analysis population: Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.

Groups in this outcome

Ipilimumab Plus gp100

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.

Ipilimumab Monotherapy

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ipilimumab Plus gp100403
Ipilimumab Monotherapy137
gp100136

Reported measurements

12-Month Survival Rate
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1000.436Not reported0.3860.485Not reported
Ipilimumab Monotherapy0.456Not reported0.3700.541Not reported
gp1000.253Not reported0.1810.329Not reported
18-Month Survival Rate
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1000.300Not reported0.2540.347Not reported
Ipilimumab Monotherapy0.332Not reported0.2490.417Not reported
gp1000.163Not reported0.1010.230Not reported
24-Month Survival Rate
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1000.216Not reported0.1720.261Not reported
Ipilimumab Monotherapy0.235Not reported0.1600.315Not reported
gp1000.137Not reported0.0800.200Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.386
        upper Limit
        0.485
        value
        0.436
      2. group Id
        OG001
        lower Limit
        0.370
        upper Limit
        0.541
        value
        0.456
      3. group Id
        OG002
        lower Limit
        0.181
        upper Limit
        0.329
        value
        0.253
    title
    12-Month Survival Rate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.254
        upper Limit
        0.347
        value
        0.300
      2. group Id
        OG001
        lower Limit
        0.249
        upper Limit
        0.417
        value
        0.332
      3. group Id
        OG002
        lower Limit
        0.101
        upper Limit
        0.230
        value
        0.163
    title
    18-Month Survival Rate
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.172
        upper Limit
        0.261
        value
        0.216
      2. group Id
        OG001
        lower Limit
        0.160
        upper Limit
        0.315
        value
        0.235
      3. group Id
        OG002
        lower Limit
        0.080
        upper Limit
        0.200
        value
        0.137
    title
    24-Month Survival Rate
denoms
  1. counts
    1. group Id
      OG000
      value
      403
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      136
    units
    Participants
description
The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    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
    OG002
    title
    gp100
param Type
NUMBER
population Description
Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.
reporting Status
POSTED
time Frame
Month 12, Month 18, Month 24
title
12-, 18-, and 24-Month Survival Rates
type
SECONDARY
unit Of Measure
probability

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

Preserved source evidence · Not medical advice