Brief Title
A Trial Evaluating TG4050 in Ovarian Carcinoma.
Official Title
A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.
Brief Summary
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Safety and tolerability (Adverse Event reported per CTCAE v5)
Secondary Outcome
Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria
Condition
Ovarian Carcinoma
Intervention
TG4050
Study Arms / Comparison Groups
TG4050 arm
Description: Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
23
Start Date
December 9, 2019
Completion Date
September 2024
Primary Completion Date
September 2023
Eligibility Criteria
Inclusion Criteria:
1. Signed written informed consent.
2. Female patients ≥ 18 years
3. Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or
primary peritoneal carcinoma.
4. 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.
5. Patients must have achieved a complete response to therapy
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment
period initiation
7. Adequate hematological, hepatic and renal functions.
Exclusion Criteria:
1. 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)
2. Patients with other active malignancy ≤ 3 years prior to registration except
non-melanoma skin cancer, stage 0 in situ carcinoma.
3. Patient post-organ transplantation, including allogeneic stem cell or bone marrow
transplantation.
4. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS
(Acquired Immune Deficiency Syndrome).
5. Any known allergy or reaction to eggs or attributed to compounds of similar chemical
or biological composition to therapeutic vaccines/immunotherapeutic products.
6. Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).
7. Major surgery within 4 weeks of treatment start.
8. Treatment with another investigation agent within 30 days prior to TG4050 treatment
initiation.
9. Patients under chronic treatment with systemic corticosteroids or other
immunosuppressive drugs . Steroids with no or minimal systemic effect (topical,
inhalation) are allowed.
10. 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.
11. Uncontrolled intercurrent illness.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, + 33.3.88.27.91.00, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03839524
Organization ID
TG4050.01
Responsible Party
Sponsor
Study Sponsor
Transgene
Study Sponsor
, ,
Verification Date
September 2021