A Trial Evaluating TG4050 in Ovarian Carcinoma. (NCT03839524) | Clinical Trial Compass
CompletedPhase 1
A Trial Evaluating TG4050 in Ovarian Carcinoma.
United States, France64 participantsStarted 2019-12-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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 criteria
✕. 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).
What they're measuring
1
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Timeframe: Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
. 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.