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NCT03260023 · OUTCOME

Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers · Source last updated 2026-02-05

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 - 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 without liver metastasis received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab46
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab44

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab3.0Not reported2.04.4Not reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab2.8Not reported1.74.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.29
    group Description
    Efficacy will be evaluated by comparing the PFS between TG4001 arm versus TG4001 \& avelumab arm with an adaptive approach. With one-sided type I error α at 5%, 76 events are needed to reach a power of 95%, corresponding to around 80 participants enrolled. To stick with initial timelines for final analyses and limiting the loss of statistical power, PFS analysis will be performed based on at least 69 events.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Statistical analysis is performed using a one-sided log-rank unstratified test to compare Progression-Free Survival of TG4001 in combination with avelumab vs avelumab alone in participants with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies and without liver metastases at baseline. PFS will be evaluated based on RECIST1.1.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2810
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Comment
    Unstratified with one-sided p-value
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.29
    group Description
    Efficacy will be evaluated by comparing the PFS between TG4001 arm versus TG4001 \& avelumab arm with an adaptive approach. With one-sided type I error α at 5%, 76 events are needed to reach a power of 95%, corresponding to around 80 participants enrolled. To stick with initial timelines for final analyses and limiting the loss of statistical power, PFS analysis will be performed based on at least 69 events.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Statistical analysis is performed using a one-sided log-rank unstratified test to compare Progression-Free Survival of TG4001 in combination with avelumab vs avelumab alone in participants with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies and without liver metastases at baseline. PFS will be evaluated based on RECIST1.1.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2810
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Comment
    Unstratified with one-sided p-value
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        4.4
        value
        3.0
      2. group Id
        OG001
        lower Limit
        1.7
        upper Limit
        4.2
        value
        2.8
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      44
    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
  1. 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 A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
  2. description
    Participants without liver metastasis 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 - Participants Without Liver Metastases - 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
Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice