A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Study Overview
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Brief Summary
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This is a multicenter, open-label, two arms, randomized, phase I 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).

Official Title
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A Randomized Phase I Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.

Conditions
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Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Drug: TG4050


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Newly diagnosed stage III or IVA 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 Exclusion Criteria: 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 cancer immunotherapy including anti-cancer vaccines, 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 within 30 days prior to TG4050 treatment initiation Uncontrolled intercurrent illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A : Early study treatment initiation<br>TG4050 treatment initiation at completion of primary treatment | Drug: TG4050<br>* Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks<br>|
| Experimental: Arm B: Study treatment initiation at recurrence<br>TG4050 treatment initiation at the time of recurrence | Drug: TG4050<br>* Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (Adverse Event reported per CTCAE v5) | Incidence of Adverse Event reported per CTCAE v5 | Up to 2 Years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-Free Survival duration | Time from documented Complete Response after primary treatment to date of first recurrence | Up to 2 Years. | 
| Tumor response rate | Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria. | Up to 2 years. |