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NCT03260023 · OUTCOME

Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies

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
DLT
Interval / dispersion
Not reported
Time frame
From Day 1 to Day 28

What was measured

Dose limiting toxicities (DLTs) includes the following: * Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded. * Liver function test abnormality: * AST or ALT \> 5 x ULN * Total bilirubin \> 3 x ULN * Concurrent AST or ALT \> 3 x ULN and total bilirubin \> 2 x ULN * Drug related AE requiring treatment interruption for more than 2 weeks

Analysis population: Phase Ib : All participants included and who received any amount of study treatment were included in the SAF. Any participant who was assigned a participant number, but did not receive any study treatment was not included in the SAF. Phase II part 1 and Phase II part 2: the outcome measure safety and tolerability has not been defined as primary endpoint. Therefore Phase II part 1 and Phase II part 2 are not included in the analysis population for safety and tolerability as primary 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.

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

Reported measurements

Source class 1
Values in DLT · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - TG4001 5x10e6 Pfu + Avelumab0Not reportedNot reportedNot reportedNot reported
Phase I - TG4001 5x10e7 Pfu + Avelumab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Dose limiting toxicities (DLTs) includes the following: * Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded. * Liver function test abnormality: * AST or ALT \> 5 x ULN * Total bilirubin \> 3 x ULN * Concurrent AST or ALT \> 3 x ULN and total bilirubin \> 2 x ULN * Drug related AE requiring treatment interruption for more than 2 weeks
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
param Type
NUMBER
population Description
Phase Ib : All participants included and who received any amount of study treatment were included in the SAF. Any participant who was assigned a participant number, but did not receive any study treatment was not included in the SAF. Phase II part 1 and Phase II part 2: the outcome measure safety and tolerability has not been defined as primary endpoint. Therefore Phase II part 1 and Phase II part 2 are not included in the analysis population for safety and tolerability as primary endpoint.
reporting Status
POSTED
time Frame
From Day 1 to Day 28
title
Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies
type
PRIMARY
unit Of Measure
DLT

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice