A Trial Evaluating TG4050 in Ovarian Carcinoma.

Korábbi kezelés

• 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.
• Major surgery within 4 weeks of treatment start.
• Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation.
• Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
• 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.

Más betegség

• Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
• 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).
• Uncontrolled intercurrent illness.

Laborértékek

• 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)

• 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.