TriangleNCT03621982 · OUTCOME
Progression-free Survival (PFS) 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
PFS defined as the time between start of treatment and the first documentation of recurrence, progression, or death for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Analysis population: Efficacy Analysis Set: The Efficacy 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. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.
Groups in this outcome
ADCT-301 Monotherapy
Participants received 20,30, 45, 60, 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, 60,80,100,125 and 150 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 | 44 |
| ADCT-301 Combination Therapy | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy | 1.35 | Not reported | 1.18 | 1.38 | Not reported |
| ADCT-301 Combination Therapy | 1.41 | Not reported | 1.25 | 2.10 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.18
- upper Limit
- 1.38
- value
- 1.35
- group Id
- OG001
- lower Limit
- 1.25
- upper Limit
- 2.10
- value
- 1.41
- denoms
- counts
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- PFS defined as the time between start of treatment and the first documentation of recurrence, progression, or death for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 20,30, 45, 60, 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, 60,80,100,125 and 150 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: The Efficacy 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. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Progression-free Survival (PFS) 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