TriangleNCT03260023 · OUTCOME
Overall Survival (OS) : 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
- Months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From treatment start : Phase Ib, Phase II part 1 / from randomization: Phase II part 2 Cohort A through study completion, for an average of 4.5 years.
What was measured
Time from the date of first study treatment administration Phase Ib, Phase II part 1 or time from the date of randomization Phase II part 2 Cohort A to the date of death due to any cause. If a patient is not known to have died survival will be censored at the date of last contact.
Analysis population: Phase Ib: All participants included and who received any amount of study treatment. Phase II part 1: Evaluable participants' population. Phase II part 2 Cohort A: All randomized participants who were administered at least one dose of IMP(s) according to the treatment allocated at randomization. For the Phase II part 2 Cohort B, the outcome measure Overall Survival 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
Participants received 5x10e6 pfu ofTG4001 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 | 3 |
| Phase I - TG4001 5x10e7 Pfu + Avelumab | 6 |
| Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 30 |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 46 |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - TG4001 5x10e6 Pfu | 5.6 | Not reported | 5.6 | NA | Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events. |
| Phase I - TG4001 5x10e7 Pfu + Avelumab | 26.2 | Not reported | 8.7 | NA | Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events. |
| Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 10.3 | Not reported | 6.2 | 13.3 | Not reported |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab | 16.6 | Not reported | 10.5 | 21.7 | Not reported |
| Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab | 16.5 | Not reported | 10.0 | 19.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 5.6
- comment
- Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 8.7
- upper Limit
- NA
- value
- 26.2
- group Id
- OG002
- lower Limit
- 6.2
- upper Limit
- 13.3
- value
- 10.3
- group Id
- OG003
- lower Limit
- 10.5
- upper Limit
- 21.7
- value
- 16.6
- group Id
- OG004
- lower Limit
- 10.0
- upper Limit
- 19.6
- value
- 16.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 30
- group Id
- OG003
- value
- 46
- group Id
- OG004
- value
- 44
- units
- Participants
- description
- Time from the date of first study treatment administration Phase Ib, Phase II part 1 or time from the date of randomization Phase II part 2 Cohort A to the date of death due to any cause. If a patient is not known to have died survival will be censored at the date of last contact.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received 5x10e6 pfu ofTG4001 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
- 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
- Phase Ib: All participants included and who received any amount of study treatment. Phase II part 1: Evaluable participants' population. Phase II part 2 Cohort A: All randomized participants who were administered at least one dose of IMP(s) according to the treatment allocated at randomization. For the Phase II part 2 Cohort B, the outcome measure Overall Survival 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 through study completion, for an average of 4.5 years.
- title
- Overall Survival (OS) : Phase Ib, Phase II Part 1, Phase II Part 2 Cohort A
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice