TG4001

BIOLOGICAL2 trials

Sponsors

Transgene

Conditions

HPV-Related Anal Squamous Cell CarcinomaHPV-Related CarcinomaHPV-Related Cervical CarcinomaHPV-Related Penile Squamous Cell CarcinomaHPV-Related Vulvar Squamous Cell CarcinomaPhase Ib and Phase II part 1: HPV-16 positive recurrent or metastatic malignancies including oropharyngeal squamous cell carcinoma of head and neckanal canceranal cancer Phase II part 2: HPV-16 positive recurrent or metastatic malignancies including cervical cancer

Phase 1

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

Active, not recruitingNCT03260023

TransgeneHPV-Related Anal Squamous Cell Carcinoma, HPV-Related Carcinoma, HPV-Related Cervical Carcinoma +2

Start: 2017-09-01End: 2026-12-01Updated: 2026-02-05

A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies

Active, not recruitingCTIS2024-515119-23-00

Transgeneanal cancer, anal cancer Phase II part 2: HPV-16 positive recurrent or metastatic malignancies including cervical cancer, cervical cancer +4

Start: 2017-08-29Target: 142Updated: 2025-12-02

Related Papers

Randomized phase II trial evaluating the combination of TG4001, an HPV16 therapeutic vaccine, and avelumab (ave) in patients (pts) with immunotherapy-naïve recurrent and/or metastatic (R/M) HPV16-positive cervical or anogenital cancer.

Journal of Clinical Oncology2025-05-282 citations

Phase Ib/II trial of tipapkinogene sovacivec, a therapeutic human papillomavirus16-vaccine, in combination with avelumab in patients with advanced human papillomavirus16-positive cancers.

2023-07-1112 citations

Immunogenicity and clinical activity of tipapkinogen sovacivec (TG4001), an HPV-16 cancer vaccine: A randomized phase 2 study in advanced anogenital cancers.

Journal of Clinical Oncology2023-06-011 citations

Abstract CT045: A randomized phase II trial of TG4001 plus avelumab versus avelumab alone in recurrent/metastatic (R/M) human papilloma virus (HPV)-16 positive anogenital cancers

Cancer Research2023-04-14

Abstract 697: Extracellular vesicles (EV) - mediators of therapeutic vaccination? In vivo and in vitro characterization of EVs generated after infection of human and murine cells with therapeutic poxviruses

Cancer Research2023-04-04

793 TG4001 (Tipapkinogene sovacivec) and avelumab for recurrent/metastatic (R/M) human papilloma virus (HPV)-16+ cancers: clinical efficacy and immunogenicity

2020-11-014 citations