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A Trial Evaluating TG4050 in Ovarian Carcinoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03839524
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Transgene

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Fallopian Tube Cancer Peritoneal Carcinoma Drug: TG4050 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TG4050 arm
Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
 Drug: TG4050
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability (Adverse Event reported per CTCAE v5) [ Time Frame: At each study visit up to final safety follow up visit: every week for the first 6 weeks and then every 3 weeks ]
    Incidence of Adverse Event reported per CTCAE v5


Secondary Outcome Measures :
  1. Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria [ Time Frame: Every 3 weeks ]
    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.

  2. Best Overall Tumor Response Rate [ Time Frame: Within 21 days of treatment initiation and then every 9 weeks ]
    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.

  3. Rate of patients with immune response [ Time Frame: Days 64, 85 and 211 ]
    Percentage of patients who achieve an immune response established by the detection of antigen-specific T cell.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839524


Contacts
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Contact: Transgene EU, Clinical Operations Department + 33.3.88.27.91.00 clinicaltrials@transgene.fr

Locations
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United States, Arizona
Mayo Clinic Phoenix Recruiting
Phoenix, Arizona, United States, 85259
Principal Investigator: Dr Seetharam         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Dr Colon-Otero         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Dr Block         
France
Institut Curie Recruiting
Paris, France, 75005
Principal Investigator: Pr Le Tourneau         
Hôpital Pitié-Salpêtrière Recruiting
Paris, France, 75013
Principal Investigator: Pr Spano         
IUCT Toulouse Recruiting
Toulouse, France, 31100
Principal Investigator: Dr Martinez         
Sponsors and Collaborators
Transgene
More Information
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Responsible Party: Transgene
ClinicalTrials.gov Identifier: NCT03839524    
Other Study ID Numbers: TG4050.01
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Fallopian Tube Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
 Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders