TriangleNCT03260023 · OUTCOME
Proportion of Progressive Disease Phase II Part 2 Cohort B
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization: every 6 weeks up to 24 weeks.
What was measured
Number of participants with liver metastases at baseline who has a documented disease progression as per RECIST1.1.
Analysis population: Phase II part 2 Cohort B: All randomized participants administered with at least one dose of IMP(s) according to allocation at randomization (FAS). One participant (cohort B - Avelumab) was excluded from analysis because no IMP has been administered. Phase Ib, Phase II part 1 and Phase II part 2 Cohort A, proportion of progressive disease has not been defined as secondary endpoint. Therefore phase Ib, Phase II part 1 and Phase II part 2 Cohort A are not included in the analysis population.
Groups in this outcome
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
| Group | Source count |
|---|---|
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 5 |
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 4 |
Reported measurements
Non progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Progressive disease <= 6 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
Progressive disease <= 12 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 3 | Not reported | Not reported | Not reported | Not reported |
Progressive disease <= 24 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Non progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Progressive disease <= 6 weeks
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Progressive disease <= 12 weeks
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Progressive disease <= 24 weeks
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Number of participants with liver metastases at baseline who has a documented disease progression as per RECIST1.1.
- groups
- description
- Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
- id
- OG000
- title
- Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
- description
- Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
- id
- OG001
- title
- Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Phase II part 2 Cohort B: All randomized participants administered with at least one dose of IMP(s) according to allocation at randomization (FAS). One participant (cohort B - Avelumab) was excluded from analysis because no IMP has been administered. Phase Ib, Phase II part 1 and Phase II part 2 Cohort A, proportion of progressive disease has not been defined as secondary endpoint. Therefore phase Ib, Phase II part 1 and Phase II part 2 Cohort A are not included in the analysis population.
- reporting Status
- POSTED
- time Frame
- From randomization: every 6 weeks up to 24 weeks.
- title
- Proportion of Progressive Disease Phase II Part 2 Cohort B
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice