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NCT00094653 · OUTCOME

Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)

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
participants
Interval / dispersion
Not reported
Time frame
BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.

What was measured

Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations \>=4 weeks apart, no evidence of PD. PR: \>=50% ↓ in sum of products of longest diameter \& greatest perpendicular diameter of all target lesions compared to baseline by 2 observations \>=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ \>=25% in sum of products of longest diameter \& greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of \>= 1 new lesion.

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

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1001Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy2Not reportedNot reportedNot reportedNot reported
gp1000Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10022Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy13Not reportedNot reportedNot reportedNot reported
gp1002Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10058Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy24Not reportedNot reportedNot reportedNot reported
gp10013Not reportedNot reportedNot reportedNot reported
Progressed Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp100239Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy70Not reportedNot reportedNot reportedNot reported
gp10089Not reportedNot reportedNot reportedNot reported
Not Evaluated, Missing, or Unknown
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10083Not reportedNot reportedNot reportedNot reported
Ipilimumab Monotherapy28Not reportedNot reportedNot reportedNot reported
gp10032Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        2
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        13
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        239
      2. group Id
        OG001
        value
        70
      3. group Id
        OG002
        value
        89
    title
    Progressed Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        32
    title
    Not Evaluated, Missing, or Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      403
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      136
    units
    Participants
description
Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations \>=4 weeks apart, no evidence of PD. PR: \>=50% ↓ in sum of products of longest diameter \& greatest perpendicular diameter of all target lesions compared to baseline by 2 observations \>=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ \>=25% in sum of products of longest diameter \& greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of \>= 1 new lesion.
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
BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.
title
Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice