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Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

NCT03260023 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2026-02-05

Study results available
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Summary

The study will consist of two parts :

In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 participants at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-participant dose escalation.

In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of participants with recurrent or metastatic HPV-16 positive advanced malignancies.

In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in participants with HPV-16 positive advanced malignancies.

In both phases, evaluation of tumor response will be done locally according to RECIST 1.1.

All participants will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first.

Conditions

  • HPV-Related Carcinoma
  • HPV-Related Cervical Carcinoma
  • HPV-Related Anal Squamous Cell Carcinoma
  • HPV-Related Penile Squamous Cell Carcinoma
  • HPV-Related Vulvar Squamous Cell Carcinoma

Interventions

BIOLOGICAL

TG4001

PhIb: Dose escalation PhII: Established RP2D for TG4001

DRUG

Avelumab

Anti PD-L1

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Transgene

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2024-09-18
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03260023 on ClinicalTrials.gov