TriangleNCT00094653 · OUTCOME
Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 12, Week 24
What was measured
PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
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
Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 0.491 | Not reported | 0.441 | 0.539 | Not reported |
| Ipilimumab Monotherapy | 0.577 | Not reported | 0.489 | 0.655 | Not reported |
| gp100 | 0.485 | Not reported | 0.396 | 0.567 | Not reported |
Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 0.164 | Not reported | 0.129 | 0.203 | Not reported |
| Ipilimumab Monotherapy | 0.240 | Not reported | 0.171 | 0.315 | Not reported |
| gp100 | 0.100 | Not reported | 0.056 | 0.159 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.441
- upper Limit
- 0.539
- value
- 0.491
- group Id
- OG001
- lower Limit
- 0.489
- upper Limit
- 0.655
- value
- 0.577
- group Id
- OG002
- lower Limit
- 0.396
- upper Limit
- 0.567
- value
- 0.485
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.129
- upper Limit
- 0.203
- value
- 0.164
- group Id
- OG001
- lower Limit
- 0.171
- upper Limit
- 0.315
- value
- 0.240
- group Id
- OG002
- lower Limit
- 0.056
- upper Limit
- 0.159
- value
- 0.100
- title
- Week 24
- denoms
- counts
- group Id
- OG000
- value
- 403
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 136
- units
- Participants
- description
- PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
- 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
- MEDIAN
- 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
- Week 12, Week 24
- title
- Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice