TriangleNCT00094653 · OUTCOME
Time to Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
What was measured
Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator.
Analysis population: Responder subjects in 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 | 23 |
| Ipilimumab Monotherapy | 15 |
| gp100 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ipilimumab Plus gp100 | 3.324 | 0.9561 | 2.10 | 5.59 | Not reported |
| Ipilimumab Monotherapy | 3.176 | 0.7629 | 2.60 | 5.52 | Not reported |
| gp100 | 2.743 | 0.0697 | 2.69 | 2.79 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.10
- spread
- 0.9561
- upper Limit
- 5.59
- value
- 3.324
- group Id
- OG001
- lower Limit
- 2.60
- spread
- 0.7629
- upper Limit
- 5.52
- value
- 3.176
- group Id
- OG002
- lower Limit
- 2.69
- spread
- 0.0697
- upper Limit
- 2.79
- value
- 2.743
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 2
- units
- Participants
- description
- Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator.
- dispersion Type
- Full Range
- 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
- MEAN
- population Description
- Responder subjects in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.
- reporting Status
- POSTED
- time Frame
- From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
- title
- Time to Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice