A Trial Evaluating TG4050 in Ovarian Carcinoma.

Study Overview
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Brief Summary
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This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.

Official Title
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A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.

Conditions
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Ovarian Carcinoma, Fallopian Tube Cancer, Peritoneal Carcinoma

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. Female patients ≥ 18 years Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma. Patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked. Patients must have achieved a complete response to therapy Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation Adequate hematological, hepatic and renal functions. Exclusion Criteria: Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTL4) Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma. Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome). Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products. Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV). Major surgery within 4 weeks of treatment start. Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation. Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed. Use of live vaccine for the prevention of infectious diseases during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration. Uncontrolled intercurrent illness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TG4050 arm<br>Patients in this arm will receive injections of TG4050 Investigational Medicinal Product. | 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 | At each study visit up to final safety follow up visit: every week for the first 6 weeks and then every 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria | Percentage of patients with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to pre-treatment CA-125 serum level per the GCIC criteria. | Every 3 weeks | 
| Best Overall Tumor Response Rate | Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria over the the total number of patients evaluable. | Within 21 days of treatment initiation and then every 9 weeks | 
| Rate of patients with immune response | Percentage of patients who achieve an immune response established by the detection of antigen-specific T cell. | Days 64, 85 and 211 |