TriangleNCT03260023 · OUTCOME
Progression Free Survival (PFS) (Phase Ib, Phase II Part 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
- From treatment start (phase Ib, phase II part 1): Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
What was measured
PFS is defined as the time from the date of first study treatment administration (Phase Ib, Phase II Part1) to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
Analysis population: For Phase Ib: All participants included and who received any amount of study treatment. For phase II part 1: Evaluable participants population (EPP) Phase II part 2, cohort A and cohort B : the outcome measure PFS has not been defined as secondary endpoint. Therefore Phase II part 2, cohort A and cohort B are not included in the analysis population for PFS as secondary endpoint.
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.
| Group | Source count |
|---|---|
| Phase I - TG4001 5x10e6 Pfu + Avelumab | 3 |
| Phase I - TG4001 5x10e7 Pfu + Avelumab | 6 |
| Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - TG4001 5x10e6 Pfu + Avelumab | 1.6 | Not reported | 1.4 | NA | Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events. |
| Phase I - TG4001 5x10e7 Pfu + Avelumab | 12.0 | Not reported | 1.2 | 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 | 1.5 | Not reported | 1.4 | 5.5 | 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
- 1.4
- upper Limit
- NA
- value
- 1.6
- comment
- Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 12.0
- group Id
- OG002
- lower Limit
- 1.4
- upper Limit
- 5.5
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 30
- units
- Participants
- description
- PFS is defined as the time from the date of first study treatment administration (Phase Ib, Phase II Part1) to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
- dispersion Type
- 95% Confidence Interval
- 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
- param Type
- MEDIAN
- population Description
- For Phase Ib: All participants included and who received any amount of study treatment. For phase II part 1: Evaluable participants population (EPP) Phase II part 2, cohort A and cohort B : the outcome measure PFS has not been defined as secondary endpoint. Therefore Phase II part 2, cohort A and cohort B are not included in the analysis population for PFS as secondary endpoint.
- reporting Status
- POSTED
- time Frame
- From treatment start (phase Ib, phase II part 1): Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
- title
- Progression Free Survival (PFS) (Phase Ib, Phase II Part 1)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice