TG4050: Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Signed written informed consent
2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
3. Female or male patients, aged at least 18 years
4. Patients in Complete Response after treatment of their primary tumor.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
6. Adequate hematological, hepatic and renal functions
Exclusion Criteria:
1. 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.
2. 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.
3. Other active malignancy requiring concurrent systemic intervention.
4. Patients with previous malignancies other than the target malignancy to be investigated in this trial
5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
7. 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)
8. Treatment with another investigational agent since the beginning of the screening period
9. Uncontrolled intercurrent illness
Primary outcome measure(s)
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5) — Up to 2 Years. Incidence of Adverse Event reported per CTCAE v5.
Phase I/II: Disease-Free Survival — Up to 2 years. Time from randomization to documented recurrence of disease.
Trial sites (14)
Facility
City
Region
Status
Mayo Clinic Jacksonville
Jacksonville
Florida
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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