TriangleNCT03797326 · OUTCOME
Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
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
- Up to approximately 66 months
What was measured
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is 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 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) | 3.5 | Not reported | 2.3 | 4.1 | Not reported |
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 3.4 | Not reported | 2.1 | 4.1 | Not reported |
| Cohort D2: Colorectal Cancer (Lenva) | 3.4 | Not reported | 2.1 | 4.8 | Not reported |
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 3.0 | Not reported | 2.8 | 4.1 | Not reported |
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 4.1 | Not reported | 3.6 | 5.9 | Not reported |
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 2.1 | Not reported | 2.1 | 3.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.3
- upper Limit
- 4.1
- value
- 3.5
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 4.1
- value
- 3.4
- group Id
- OG002
- lower Limit
- 2.1
- upper Limit
- 4.8
- value
- 3.4
- group Id
- OG003
- lower Limit
- 2.8
- upper Limit
- 4.1
- value
- 3.0
- group Id
- OG004
- lower Limit
- 3.6
- upper Limit
- 5.9
- value
- 4.1
- group Id
- OG005
- lower Limit
- 2.1
- upper Limit
- 3.1
- value
- 2.1
- 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
- PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is 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 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
- MEDIAN
- 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
- Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice