TriangleNCT03797326 · OUTCOME
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)
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. For participants with GBM, response was assessed according to RANO criteria whereby 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): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
Analysis population: All allocated participants who received at least 1 dose of study intervention.
Groups in this outcome
Cohort C: Gastric 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 once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort D1: Colorectal 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.
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort E: Glioblastoma Multiforma (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.
Cohort F: Biliary Tract 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.
Cohort G: Pancreatic 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 C: Gastric Cancer (Lenva + Pembro) | 99 |
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 105 |
| Cohort D2: Colorectal Cancer (Lenva) | 30 |
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 101 |
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 102 |
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 103 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort C: Gastric Cancer (Lenva + Pembro) | 15.2 | Not reported | 8.7 | 23.8 | Not reported |
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 14.3 | Not reported | 8.2 | 22.5 | Not reported |
| Cohort D2: Colorectal Cancer (Lenva) | 6.7 | Not reported | 0.8 | 22.1 | Not reported |
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 21.8 | Not reported | 14.2 | 31.1 | Not reported |
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 17.6 | Not reported | 10.8 | 26.4 | Not reported |
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 7.8 | Not reported | 3.4 | 14.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.7
- upper Limit
- 23.8
- value
- 15.2
- group Id
- OG001
- lower Limit
- 8.2
- upper Limit
- 22.5
- value
- 14.3
- group Id
- OG002
- lower Limit
- 0.8
- upper Limit
- 22.1
- value
- 6.7
- group Id
- OG003
- lower Limit
- 14.2
- upper Limit
- 31.1
- value
- 21.8
- group Id
- OG004
- lower Limit
- 10.8
- upper Limit
- 26.4
- value
- 17.6
- group Id
- OG005
- lower Limit
- 3.4
- upper Limit
- 14.7
- value
- 7.8
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 105
- group Id
- OG002
- value
- 30
- group Id
- OG003
- value
- 101
- group Id
- OG004
- value
- 102
- group Id
- OG005
- value
- 103
- 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. For participants with GBM, response was assessed according to RANO criteria whereby 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): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
- dispersion Type
- 95% Confidence Interval
- groups
- 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 once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- Cohort C: Gastric 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 D1: Colorectal Cancer (Lenva + Pembro)
- description
- Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG002
- title
- Cohort D2: Colorectal Cancer (Lenva)
- 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
- OG003
- title
- Cohort E: Glioblastoma Multiforma (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
- OG004
- title
- Cohort F: Biliary Tract 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
- OG005
- title
- Cohort G: Pancreatic 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) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice