TriangleNCT03621982 · OUTCOME
Duration of Response (DOR) as Per RECIST v 1.1
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 3 years
What was measured
DOR is defined among objective responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression (based on radiographic or clinical progression at end of treatment \[EOT\]/end of study \[EOS\]) or death due to any cause.
Analysis population: Efficacy Analysis Set: This analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death were also included. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3. Includes participants who experienced CR or PR only.
Groups in this outcome
ADCT-301 Monotherapy
Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Combination Therapy
Participants received 20, 30, 45, 60, 80, 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
| Group | Source count |
|---|---|
| ADCT-301 Monotherapy | 0 |
| ADCT-301 Combination Therapy | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Combination Therapy | 9.26 | Not reported | 3.15 | NA | Upper limit could not be calculated as not enough participants achieved a response. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit could not be calculated as not enough participants achieved a response.
- group Id
- OG001
- lower Limit
- 3.15
- upper Limit
- NA
- value
- 9.26
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- DOR is defined among objective responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression (based on radiographic or clinical progression at end of treatment \[EOT\]/end of study \[EOS\]) or death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- ADCT-301 Monotherapy
- description
- Participants received 20, 30, 45, 60, 80, 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG001
- title
- ADCT-301 Combination Therapy
- param Type
- MEDIAN
- population Description
- Efficacy Analysis Set: This analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death were also included. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3. Includes participants who experienced CR or PR only.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Duration of Response (DOR) as Per RECIST v 1.1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice