TriangleNCT03621982 · OUTCOME
Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
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 3 years
What was measured
The ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The overall response category was derived based on response assessment performed on or before the start of subsequent anti-cancer therapy.
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 assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death (after receiving study drug) were also included. 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, 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 and 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 | 44 |
| ADCT-301 Combination Therapy | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy | 0 | Not reported | 0 | 0 | Not reported |
| ADCT-301 Combination Therapy | 15.2 | Not reported | 5.1 | 31.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 5.1
- upper Limit
- 31.9
- value
- 15.2
- denoms
- counts
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- The ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The overall response category was derived based on response assessment performed on or before the start of subsequent anti-cancer therapy.
- 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 and 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
- NUMBER
- 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 assessment. Participants who did not have a post-Baseline assessment due to early clinical progression or death (after receiving study drug) were also included. 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
- Overall Response Rate (ORR) According to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice