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NCT03260023 · OUTCOME

Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A

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
Not reported
Time frame
From treatment start (phase Ib) / randomization (phase II part 2) : 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: For Phase Ib / Phase II part 2 Cohort A: All participants who received at least one dose of IMP(s) according to treatment allocation. Phase II part 1 and phase II part 2 Cohort B: the outcome measure ORR has not been defined as secondary endpoint. Therefore Phase II part 1 and phase II part 2 Cohort B are not included in the analysis population for ORR 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 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase I - TG4001 5x10e6 Pfu + Avelumab3
Phase I - TG4001 5x10e7 Pfu + Avelumab6
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

Overall Response Rate (ORR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - TG4001 5x10e6 Pfu + Avelumab0.0Not reportedNot reportedNot reportedNot reported
Phase I - TG4001 5x10e7 Pfu + Avelumab50.0Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab15.2Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab13.6Not reportedNot reportedNot reportedNot reported
Disease Control Rate (DCR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - TG4001 5x10e6 Pfu + Avelumab33.3Not reportedNot reportedNot reportedNot reported
Phase I - TG4001 5x10e7 Pfu + Avelumab83.3Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab65.2Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab68.2Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - TG4001 5x10e6 Pfu + Avelumab0.0Not reportedNot reportedNot reportedNot reported
Phase I - TG4001 5x10e7 Pfu + Avelumab0.0Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab8.7Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab2.3Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - TG4001 5x10e6 Pfu + Avelumab0.0Not reportedNot reportedNot reportedNot reported
Phase I - TG4001 5x10e7 Pfu + Avelumab50.0Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab6.5Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab11.4Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - TG4001 5x10e6 Pfu + Avelumab33.3Not reportedNot reportedNot reportedNot reported
Phase I - TG4001 5x10e7 Pfu + Avelumab33.3Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab50.0Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab54.5Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - TG4001 5x10e6 Pfu + Avelumab66.7Not reportedNot reportedNot reportedNot reported
Phase I - TG4001 5x10e7 Pfu + Avelumab16.7Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab34.8Not reportedNot reportedNot reportedNot reported
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab31.8Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    In Phase II part 2 cohort A, statistical Test stratified by indication to compare the Overall Response Rate between TG4001+Avelumab versus Avelumab alone.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    OTHER
    p Value
    0.832
    p Value Comment
    At level 0.05 without adjustments for multiplicity testing, pvalue is calculated using Cochran-Mantel-Haenszel Chi-Square test.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Description
    In Phase II part 2 cohort A, statistical Test stratified by indication to compare the Overall Response Rate between TG4001+Avelumab versus Avelumab alone.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    OTHER
    p Value
    0.832
    p Value Comment
    At level 0.05 without adjustments for multiplicity testing, pvalue is calculated using Cochran-Mantel-Haenszel Chi-Square test.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        50.0
      3. group Id
        OG002
        value
        15.2
      4. group Id
        OG003
        value
        13.6
    title
    Overall Response Rate (ORR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        83.3
      3. group Id
        OG002
        value
        65.2
      4. group Id
        OG003
        value
        68.2
    title
    Disease Control Rate (DCR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        8.7
      4. group Id
        OG003
        value
        2.3
    title
    Complete Response (CR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        50.0
      3. group Id
        OG002
        value
        6.5
      4. group Id
        OG003
        value
        11.4
    title
    Partial Response (PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        33.3
      3. group Id
        OG002
        value
        50.0
      4. group Id
        OG003
        value
        54.5
    title
    Stable Disease (SD)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        66.7
      2. group Id
        OG001
        value
        16.7
      3. group Id
        OG002
        value
        34.8
      4. group Id
        OG003
        value
        31.8
    title
    Progressive Disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      46
    4. group Id
      OG003
      value
      44
    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.
groups
  1. 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
  2. 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
  3. 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
    OG002
    title
    Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
  4. description
    Participants 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 - Participants Without Liver Metastases - Avelumab
param Type
NUMBER
population Description
For Phase Ib / Phase II part 2 Cohort A: All participants who received at least one dose of IMP(s) according to treatment allocation. Phase II part 1 and phase II part 2 Cohort B: the outcome measure ORR has not been defined as secondary endpoint. Therefore Phase II part 1 and phase II part 2 Cohort B are not included in the analysis population for ORR as secondary endpoint.
reporting Status
POSTED
time Frame
From treatment start (phase Ib) / randomization (phase II part 2) : Every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.
title
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice