TriangleNCT01848834 · OUTCOME
Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 Human Papilloma Virus (HPV)-Positive Participants
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
- Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016
What was measured
ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who had tumors which were HPV positive and who experienced a CR or PR in the combined Cohorts B2 and B2 was presented for the first course of pembrolizumab treatment per protocol.
Analysis population: The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment.
Groups in this outcome
Cohorts B & B2: Head & Neck Cancer HPV-Positive Participants
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks or pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
| Group | Source count |
|---|---|
| Cohorts B & B2: Head & Neck Cancer HPV-Positive Participants | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohorts B & B2: Head & Neck Cancer HPV-Positive Participants | 21.9 | Not reported | 12.5 | 34.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.5
- upper Limit
- 34.0
- value
- 21.9
- denoms
- counts
- group Id
- OG000
- value
- 64
- units
- Participants
- description
- ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who had tumors which were HPV positive and who experienced a CR or PR in the combined Cohorts B2 and B2 was presented for the first course of pembrolizumab treatment per protocol.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks or pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
- id
- OG000
- title
- Cohorts B & B2: Head & Neck Cancer HPV-Positive Participants
- param Type
- NUMBER
- population Description
- The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016
- title
- Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 Human Papilloma Virus (HPV)-Positive Participants
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice