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
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Carcinoma Fallopian Tube Cancer Peritoneal Carcinoma||Drug: TG4050||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: TG4050 arm
Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.
- 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
- 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.
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
|Contact: Transgene EU, Clinical Operations Department||+ email@example.com|
|United States, Arizona|
|Mayo Clinic Phoenix||Recruiting|
|Phoenix, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Toulouse, France, 31100|