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NCT03260023 · OUTCOME

Phase II Part 1: Overall Response Rate (ORR) 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.

What was measured

Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Analysis population: Phase II part 1 (Evaluable per protocol): Participants dosed with both IMPs and with at least baseline and post-baseline evaluable CT-scan at week 6 according to RECIST 1.1 and no major inc/exc, dosing or protocol violation, except if participant progressed or died due to disease. Phase Ib and phase II part 2: the outcome measure ORR has not been defined as primary endpoint. Therefore Phase Ib and phase II part 2 are not included in the analysis population for ORR as primary endpoint.

Groups in this outcome

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 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 1 - TG4001 5x10e7 Pfu + Avelumab30

Reported measurements

Overall Response Rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab16.67Not reported5.6434.72Not reported
Disease Control Rate (DCR)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab46.67Not reported28.3465.67Not reported
Complete Response (CR)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab3.33Not reported0.0817.22Not reported
Partial Response (PR)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab13.33Not reported3.7630.72Not reported
Stable Disease (SD)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab30.0Not reported14.7349.40Not reported
Progressive disease (PD)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab53.33Not reported34.3371.66Not reported

Source statistical analyses

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

  1. group Description
    A Simon's two-stage design will be used. The null hypothesis for response rate H0 is set at 10% corresponding to the response rate observed in second line participants, the alternate hypothesis of efficacy is set at HA=25%, the type I error α is set at 5% one sided, the type II error β is set at 20% (power=80%).
    group Ids
    1. OG000
    non Inferiority Comment
    Enough participants will be treated to obtain 22 evaluable as a first stage. If at least 3/22 participants are considered responders, the enrolment will be continued, otherwise it will be stopped. For the second stage of the trial, enough participants will be treated to obtain a total of 40 evaluable participants and consider the study positive if at least 8/40 of them are considered responders.
    non Inferiority Type
    OTHER
    other Analysis Description
    With a hierarchical strategy on the final analysis, a subgroup analysis performed in oropharyngeal SCCHN patients and with a null hypothesis for response rate (H0) set at 10% and the alternative hypothesis of efficacy set at HA = 35%, 18 oropharyngeal SCCHN patients would have been needed to reach a power of 81% and actual alpha at 2.8%. This analysis would have been considered positive with at least 5 responders among the 18 SCCHN patients. The second stage of the Simon's design has not been done following the decision to exclude oropharyngeal SCCHN and to change to a randomized controlled two-arms study (phase II part 2).
Complete source fields
analyses
  1. group Description
    A Simon's two-stage design will be used. The null hypothesis for response rate H0 is set at 10% corresponding to the response rate observed in second line participants, the alternate hypothesis of efficacy is set at HA=25%, the type I error α is set at 5% one sided, the type II error β is set at 20% (power=80%).
    group Ids
    1. OG000
    non Inferiority Comment
    Enough participants will be treated to obtain 22 evaluable as a first stage. If at least 3/22 participants are considered responders, the enrolment will be continued, otherwise it will be stopped. For the second stage of the trial, enough participants will be treated to obtain a total of 40 evaluable participants and consider the study positive if at least 8/40 of them are considered responders.
    non Inferiority Type
    OTHER
    other Analysis Description
    With a hierarchical strategy on the final analysis, a subgroup analysis performed in oropharyngeal SCCHN patients and with a null hypothesis for response rate (H0) set at 10% and the alternative hypothesis of efficacy set at HA = 35%, 18 oropharyngeal SCCHN patients would have been needed to reach a power of 81% and actual alpha at 2.8%. This analysis would have been considered positive with at least 5 responders among the 18 SCCHN patients. The second stage of the Simon's design has not been done following the decision to exclude oropharyngeal SCCHN and to change to a randomized controlled two-arms study (phase II part 2).
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.64
        upper Limit
        34.72
        value
        16.67
    title
    Overall Response Rate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.34
        upper Limit
        65.67
        value
        46.67
    title
    Disease Control Rate (DCR)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.08
        upper Limit
        17.22
        value
        3.33
    title
    Complete Response (CR)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.76
        upper Limit
        30.72
        value
        13.33
    title
    Partial Response (PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.73
        upper Limit
        49.40
        value
        30.0
    title
    Stable Disease (SD)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.33
        upper Limit
        71.66
        value
        53.33
    title
    Progressive disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
param Type
NUMBER
population Description
Phase II part 1 (Evaluable per protocol): Participants dosed with both IMPs and with at least baseline and post-baseline evaluable CT-scan at week 6 according to RECIST 1.1 and no major inc/exc, dosing or protocol violation, except if participant progressed or died due to disease. Phase Ib and phase II part 2: the outcome measure ORR has not been defined as primary endpoint. Therefore Phase Ib and phase II part 2 are not included in the analysis population for ORR as primary endpoint.
reporting Status
POSTED
time Frame
From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.
title
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice