Status:
COMPLETED
A Trial Evaluating TG4050 in Ovarian Carcinoma.
Lead Sponsor:
Transgene
Conditions:
Ovarian Carcinoma
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 serou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03839524
Start Date
December 9 2019
End Date
October 8 2024
Last Update
November 14 2025
Active Locations (6)
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1
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85259
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
4
Institut Curie
Paris, France, 75005