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A Trial Evaluating TG4050 in Ovarian Carcinoma.

NCT ID: NCT03839524

Last Updated: 2025-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2024-10-08

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.

Detailed Description

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Conditions

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Ovarian Carcinoma Fallopian Tube Cancer Peritoneal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TG4050 arm

Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.

Group Type EXPERIMENTAL

TG4050

Intervention Type DRUG

Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.

Interventions

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TG4050

Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Transgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic Phoenix

Phoenix, Arizona, United States

Site Status

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Institut Curie

Paris, , France

Site Status

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

IUCT Toulouse

Toulouse, , France

Site Status

Countries

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United States France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TG4050.01

Identifier Type: -

Identifier Source: org_study_id