TriangleNCT01848834 · OUTCOME
Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2
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 experienced a CR or PR in Cohort B2 was presented for the first course of pembrolizumab treatment per protocol.
Analysis population: The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.
Groups in this outcome
Cohort B2: Head & Neck Cancer Expansion
Participants received 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 |
|---|---|
| Cohort B2: Head & Neck Cancer Expansion | 132 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort B2: Head & Neck Cancer Expansion | 18.2 | Not reported | 12.0 | 25.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 25.8
- value
- 18.2
- denoms
- counts
- group Id
- OG000
- value
- 132
- 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 experienced a CR or PR in Cohort B2 was presented for the first course of pembrolizumab treatment per protocol.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 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
- Cohort B2: Head & Neck Cancer Expansion
- param Type
- NUMBER
- population Description
- The population consisted of all Cohort B2 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 for Participants in Cohort B2
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice