TriangleNCT00094653 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])
What was measured
Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first).
Analysis population: Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment.
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 | 11.47 | Not reported | 5.36 | NA | Upper limit of 95% CI was not reached because most subjects were censored and the upper bound was not estimable. |
| Ipilimumab Monotherapy | NA | Not reported | 28.09 | NA | Median duration of response was not reached because of the number of ongoing responses (ie, since most subjects did not progress-die, the median was not reached). |
| gp100 | NA | Not reported | 2.00 | NA | The limited number of responses (2) in the gp100 monotherapy group prevented a median duration from being reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not reached because most subjects were censored and the upper bound was not estimable.
- group Id
- OG000
- lower Limit
- 5.36
- upper Limit
- NA
- value
- 11.47
- comment
- Median duration of response was not reached because of the number of ongoing responses (ie, since most subjects did not progress-die, the median was not reached).
- group Id
- OG001
- lower Limit
- 28.09
- upper Limit
- NA
- value
- NA
- comment
- The limited number of responses (2) in the gp100 monotherapy group prevented a median duration from being reached.
- group Id
- OG002
- lower Limit
- 2.00
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 2
- units
- Participants
- description
- Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first).
- 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
- Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment.
- reporting Status
- POSTED
- time Frame
- from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice