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ACTIVE NOT RECRUITING
NCT04183166
PHASE1/PHASE2

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Sponsor: Transgene

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).

Official title: A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2019-12-12

Completion Date

2031-12-30

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DRUG

TG4050

Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks

Locations (14)

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Hôpital Saint André - CHU de Bordeaux

Bordeaux, France

Hôpital de la Timone

Marseille, France

Institut Curie

Paris, France

IUCT Toulouse

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Hospital Universitari Vall d Hebrón

Barcelona, Spain

Institut Català d Oncologia - Hospital Duran i Reynals

Barcelona, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Regional Universitario de Málaga - Hospital Civil

Málaga, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

NHS Clatterbridge Cancer Center

Liverpool, United Kingdom

Aintree University Hospital NHS Fondation Trust

Liverpool, United Kingdom