TriangleNCT03260023 · OUTCOME
Duration of Overall Response (DoR): Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- Full Range
- Time frame
- From treatment start Phase Ib, Phase II part 1 / from randomization Phase II part 2 Cohort A : every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 2.5 years.
What was measured
Duration of overall response in weeks (DoR) applies only to patients whose best overall response is CR or PR. The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as first documented disease progression or death due to underlying cancer.
Analysis population: For phase Ib, phase II part 1 and phase II part 2 Cohort A, analysis population consists of all included participants who were dosed with IMP(s) according to treatment allocation and who have a confirmed response according to RECIST1.1. For Phase II part 2 Cohort B, the outcome measure duration of overall response has not been defined as secondary endpoint. Therefore Phase II part 2 cohort B is not included in the analysis population.
Groups in this outcome
Phase I - TG4001 5x10e6 Pfu Avelumab
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
Phase I - TG4001 5x10e7 Pfu Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
Phase II Part 2 - Cohort A - Participants Without 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 A - Participants Without 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 I - TG4001 5x10e6 Pfu Avelumab | 0 |
| Phase I - TG4001 5x10e7 Pfu Avelumab | 3 |
| Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 5 |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 7 |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - TG4001 5x10e7 Pfu Avelumab | 53.7 | Not reported | 40.7 | 239.7 | Not reported |
| Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 25.1 | Not reported | 22.4 | 228.1 | Not reported |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 90.3 | Not reported | 12.1 | 138.4 | Not reported |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 55.9 | Not reported | 18.3 | 121.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 40.7
- upper Limit
- 239.7
- value
- 53.7
- group Id
- OG002
- lower Limit
- 22.4
- upper Limit
- 228.1
- value
- 25.1
- group Id
- OG003
- lower Limit
- 12.1
- upper Limit
- 138.4
- value
- 90.3
- group Id
- OG004
- lower Limit
- 18.3
- upper Limit
- 121.0
- value
- 55.9
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 6
- units
- Participants
- description
- Duration of overall response in weeks (DoR) applies only to patients whose best overall response is CR or PR. The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as first documented disease progression or death due to underlying cancer.
- dispersion Type
- Full Range
- groups
- description
- Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
- id
- OG000
- title
- Phase I - TG4001 5x10e6 Pfu Avelumab
- description
- Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
- id
- OG001
- title
- Phase I - TG4001 5x10e7 Pfu Avelumab
- description
- Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
- id
- OG002
- title
- Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
- 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
- OG003
- title
- Phase II Part 2 - Cohort A - Participants Without 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
- OG004
- title
- Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
- param Type
- MEDIAN
- population Description
- For phase Ib, phase II part 1 and phase II part 2 Cohort A, analysis population consists of all included participants who were dosed with IMP(s) according to treatment allocation and who have a confirmed response according to RECIST1.1. For Phase II part 2 Cohort B, the outcome measure duration of overall response has not been defined as secondary endpoint. Therefore Phase II part 2 cohort B is not included in the analysis population.
- reporting Status
- POSTED
- time Frame
- From treatment start Phase Ib, Phase II part 1 / from randomization Phase II part 2 Cohort A : every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 2.5 years.
- title
- Duration of Overall Response (DoR): Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice