Squamous Cell Carcinoma of Head and Neck
Conditions
Brief 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).
Interventions
DRUGTG4050
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks
Sponsors
Transgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5) | Up to 2 years. | Incidence of Adverse Event reported per CTCAE v5. |
| Phase I/II: Distant Metastases-Free Survival | Up to 2 years. | Time from randomization to documented first occurrence of distant metastasis. |
| Phase I: Disease-Free Survival | Up to 2 Years. | Time from randomization to documented recurrence of disease. |
| Phase I/II: Overall Response Rate in patients with recurrent disease | Up to 2 years. | Percentage of patients with a best overall response of complete response or partial response according to RECIST, version 1.1 criteria. |
| Phase I/II: Loco-Regional Relapse-Free Survival | Up to 2 years. | Time from randomization to documented loco-regional recurrence. |
| Phase I: Tumor response rate | Up to 2 years. | Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria. |
Countries
France, Spain, United Kingdom, United States
Outcome results
None listed