TriangleNCT03260023 · OUTCOME
Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification
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 randomization: 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 randomization 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: Phase II part 2 Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint. Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.
Groups in this outcome
Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases 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 - Cervix Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases 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 - Anal Cancer - Avelumab
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
Participants without liver metastases 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 - Genital Cancer - Avelumab
Participants without liver metastases 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 A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab | 25 |
| Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab | 24 |
| Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab | 14 |
| Phase II Part 2 - Cohort A - Anal Cancer - Avelumab | 13 |
| Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab | 7 |
| Phase II Part 2 - Cohort A - Genital Cancer - Avelumab | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab | 4.3 | Not reported | 1.7 | 12.7 | Not reported |
| Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab | 2.1 | Not reported | 1.4 | 2.8 | Not reported |
| Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab | 3.0 | Not reported | 1.5 | 5.6 | Not reported |
| Phase II Part 2 - Cohort A - Anal Cancer - Avelumab | 3.0 | Not reported | 1.4 | NA | Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events. |
| Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab | 1.6 | Not reported | 1.4 | 5.6 | Not reported |
| Phase II Part 2 - Cohort A - Genital Cancer - Avelumab | 7.2 | Not reported | 2.8 | NA | Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.7
- upper Limit
- 12.7
- value
- 4.3
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 2.8
- value
- 2.1
- group Id
- OG002
- lower Limit
- 1.5
- upper Limit
- 5.6
- value
- 3.0
- comment
- Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
- group Id
- OG003
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 3.0
- group Id
- OG004
- lower Limit
- 1.4
- upper Limit
- 5.6
- value
- 1.6
- comment
- Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.
- group Id
- OG005
- lower Limit
- 2.8
- upper Limit
- NA
- value
- 7.2
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- PFS is defined as the time from the date of randomization 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
- 90% Confidence Interval
- groups
- description
- Participants without liver metastases 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 A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab
- description
- Participants without liver metastases 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 A - Cervix Cancer - Avelumab
- description
- Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
- id
- OG002
- title
- Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
- description
- Participants without liver metastases received 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 - Anal Cancer - Avelumab
- description
- Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 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 - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
- description
- Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
- id
- OG005
- title
- Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
- param Type
- MEDIAN
- population Description
- Phase II part 2 Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint. Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.
- reporting Status
- POSTED
- time Frame
- From randomization: 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 II Part 2 Cohort A by Stratification
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice