Trials / Active Not Recruiting

Active Not RecruitingNCT03260023

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

A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.

Status: Active Not Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 143 (actual)

Sponsor: Transgene · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	TG4001	PhIb: Dose escalation PhII: Established RP2D for TG4001
DRUG	Avelumab	Anti PD-L1

Timeline

Start date: 2017-09-01
Primary completion: 2024-09-18
Completion: 2026-12-01
First posted: 2017-08-24
Last updated: 2026-02-05
Results posted: 2025-12-02

Locations

20 sites across 3 countries: United States, France, Spain

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03260023. Inclusion in this directory is not an endorsement.