TriangleNCT03797326 · OUTCOME
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment
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
- Up to approximately 66 months
What was measured
ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
Analysis population: All allocated participants who received at least 1 dose of study intervention.
Groups in this outcome
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 31 |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 22.6 | Not reported | 9.6 | 41.1 | Not reported |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 25.8 | Not reported | 11.9 | 44.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.6
- upper Limit
- 41.1
- value
- 22.6
- group Id
- OG001
- lower Limit
- 11.9
- upper Limit
- 44.6
- value
- 25.8
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 31
- units
- Participants
- description
- ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG001
- title
- Cohort B: Ovarian Cancer (Lenva + Pembro)
- param Type
- NUMBER
- population Description
- All allocated participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- Up to approximately 66 months
- title
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice