Evaluating TG4050 for head and neck cancer treatment
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.
This study is testing a new treatment called TG4050 to see if it can help people with advanced head and neck cancer feel better and respond well to surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Transgene Industry-sponsored |
| Locations | 14 sites (Jacksonville, Florida and 13 other locations) |
| Trial ID | NCT04183166 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, randomized phase I/II clinical trial is designed to assess the safety, tolerability, and preliminary efficacy of TG4050 in patients diagnosed with squamous cell carcinoma of the head and neck. The study will involve two arms and will focus on patients who are newly diagnosed with stage III or IV cancer that is amenable to surgical intervention. Participants will be monitored for their response to the treatment and any associated side effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with newly diagnosed stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx who are eligible for surgery.
Not a fit: Patients with other types of head and neck cancers or those who have previously received certain anti-cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced head and neck cancer.
How similar studies have performed: While this approach is novel, similar studies evaluating immunotherapies in head and neck cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jacksonville, Florida and 13 other locations
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Hôpital Saint André - CHU de Bordeaux — Bordeaux, France (Recruiting)
- Hôpital de la Timone — Marseille, France (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- IUCT Toulouse — Toulouse, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
- Hospital Universitari Vall d Hebrón — Barcelona, Spain (Recruiting)
- Institut Català d Oncologia - Hospital Duran i Reynals — Barcelona, Spain (Not_yet_recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
- Hospital Regional Universitario de Málaga - Hospital Civil — Málaga, Spain (Recruiting)
- Complejo Hospitalario Universitario de Santiago — Santiago de Compostela, Spain (Not_yet_recruiting)
- NHS Clatterbridge Cancer Center — Liverpool, United Kingdom (Recruiting)
- Aintree University Hospital NHS Fondation Trust — Liverpool, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Transgene EU, Clinical Operations Department
- Email: clinical.trials@transgene.fr
- Phone: + 33.3.88.27.91.00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.