TriangleNCT00094653 · OUTCOME
Disease Control Rate (DCR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to week 24
What was measured
Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group.
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 | Source count |
|---|---|
| Ipilimumab Plus gp100 | 403 |
| Ipilimumab Monotherapy | 137 |
| gp100 | 136 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 20.1 | Not reported | 16.3 | 24.3 | Not reported |
| Ipilimumab Monotherapy | 28.5 | Not reported | 21.1 | 36.8 | Not reported |
| gp100 | 11.0 | Not reported | 6.3 | 17.5 | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0179
- p Value Comment
- P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- p Value Comment
- P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0429
- p Value Comment
- P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0179
- p Value Comment
- P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- p Value Comment
- P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0429
- p Value Comment
- P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.3
- upper Limit
- 24.3
- value
- 20.1
- group Id
- OG001
- lower Limit
- 21.1
- upper Limit
- 36.8
- value
- 28.5
- group Id
- OG002
- lower Limit
- 6.3
- upper Limit
- 17.5
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 403
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 136
- units
- Participants
- description
- Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- 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
- 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
- Up to week 24
- title
- Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice