A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Squamous Cell Carcinoma of Head and Neck

In brief

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).

Key facts

Study ID

NCT04183166

Run by

Transgene

People needed

80

Starts

2019-12-12

Expected to finish

2031-12-30

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent
• Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
• Female or male patients, aged at least 18 years
• Patients in Complete Response after treatment of their primary tumor.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate hematological, hepatic and renal functions

You may not qualify if…

• Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies.
• Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.
• Other active malignancy requiring concurrent systemic intervention.
• Patients with previous malignancies other than the target malignancy to be investigated in this trial
• Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
• Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL)
• Treatment with another investigational agent since the beginning of the screening period
• Uncontrolled intercurrent illness

Where it is running

• 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

Full record on ClinicalTrials.gov

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