TriangleNCT03797326 · OUTCOME
Duration of Response (DOR) Per 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 66 months
What was measured
For participants who demonstrate a confirmed 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) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is 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 and had confirmed complete response or partial response.
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) | 7 |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 22.9 | Not reported | 4.2 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 15.3 | Not reported | 6.4 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- NA
- value
- 22.9
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG001
- lower Limit
- 6.4
- upper Limit
- NA
- value
- 15.3
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- For participants who demonstrate a confirmed 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) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is 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
- MEDIAN
- population Description
- All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response.
- reporting Status
- POSTED
- time Frame
- Up to approximately 66 months
- title
- Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice