Experimental combo targets Hard-to-Treat HPV cancers

NCT ID NCT03260023

Ongoing Disease control Sponsor: Transgene Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs—TG4001 (a biologic that targets HPV) and avelumab (an immunotherapy)—in people with advanced HPV-16 cancers that cannot be removed by surgery or cured by radiation. The trial has two phases: first, to find a safe dose, and second, to see if the combination shrinks tumors better than avelumab alone. About 143 participants with cervical, anal, penile, or vulvar cancers are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: TG4001 (a vaccine-like biologic) and avelumab (an immunotherapy drug)
What this could lead to: If it works, this could offer a new treatment option for people with advanced HPV-16 cancers that have stopped responding to other therapies.
What could go wrong: This is an early-phase trial (Phase 1/2) with a small number of participants. The combination may cause serious side effects, and it is not yet known if it works better than existing treatments.

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Conditions

The condition(s) this trial relates to.

anal squamous cell carcinoma cervical carcinoma human papillomavirus-related penile squamous cell carcinoma human papillomavirus-related squamous cell carcinoma neoplasm vaginal squamous cell carcinoma vulvar squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

CHU Besançon

Besançon, France
CLCC Georges-François Leclerc

Dijon, France
Centre Léon Bérard

Lyon, France
Centre Paul Strauss - ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, France
Fundación de Investigación Biomédica Hospital Clínico San Carlos

Madrid, Spain
Fundación de Investigación biomédica H. 12 de Octubre

Madrid, Spain
Hopital de la Timone

Marseille, France
Hospital General de Valencia

Valencia, Spain
Hospital Virgen de La Victoria

Málaga, Spain
Hospital Virgen de las Nieves

Granada, Spain
Hôpital Saint André - CHU de Bordeaux

Bordeaux, France
Hôpitaux Civils de Colmar - Hôpital Pasteur

Colmar, France
I.C.O. Gauducheau

Saint-Herblain, France
I.C.O. Paul Papin

Angers, France
ICO Badalona - Hospital Germans Trias i Pujol

Badalona, Spain
Institut Claudius Regaud - IUCT - Oncopole

Toulouse, France
Institut Curie

Paris, France
Institut Gustave Roussy

Villejuif, France
Mayo Clinic

Jacksonville, Florida, 32224, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States

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