Clinical Trials in Spain / NCT04183166
Active, not recruiting
Phase 1/2
A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
NCT04183166 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Squamous Cell Carcinoma of Head and Neck
Investigational drug(s) / intervention(s)
TG4050
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
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 | 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 |
More Transgene trials in Spain
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
Active, not recruiting
Other trials for the same condition
Official registry record
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.
View NCT04183166 on ClinicalTrials.gov ↗ ← All trials in Spain