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A Trial Evaluating TG4050 in Ovarian Carcinoma.

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ClinicalTrials.gov Identifier: NCT03839524
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Transgene

Tracking Information
First Submitted Date  ICMJE February 6, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE December 9, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Evaluating TG4050 in Ovarian Carcinoma.
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Carcinoma
  • Fallopian Tube Cancer
  • Peritoneal Carcinoma
Intervention  ICMJE Drug: TG4050
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.
Study Arms  ICMJE Experimental: TG4050 arm
Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
Intervention: Drug: TG4050
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2019)
13
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and have completed standard first-line platinum-based chemotherapy for whom tumor tissue has been banked from previous abdominal surgery.
  5. Patients must have achieved a complete response to therapy
  6. Adequate hematological, hepatic and renal functions

Exclusion Criteria:

  1. Patient having received:

    • Neoadjuvant chemotherapy prior to debulking surgery
    • 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, and 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 non-oncology vaccine therapy for prevention of infectious diseases during the four-week period prior to TG4050 treatment initiation planned date.
  11. Uncontrolled intercurrent illness
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Transgene EU, Clinical Operations Department + 33.3.88.27.91.00 clinicaltrials@transgene.fr
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03839524
Other Study ID Numbers  ICMJE TG4050.01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Transgene
Study Sponsor  ICMJE Transgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Transgene
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP