A Randomized, Double-blind, Placebo-controlled, Preliminary Verifying Study About Safety and Efficacy of Maintenance DCVAC/OvCa After First-line Chemotherapy Added to Standard of Care in Patients With Newly Diagnosed FIGO III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.
This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma.
• Eighteen years of age or older at the time written informed consent is obtained
• Newly diagnosed, histologically confirmed FIGO stage III or IV EOC (high-grade serous or high-grade endometrioid)
• After primary debulking surgery or after interval debulking surgery; residual disease after surgery with optimal resection as R0 or R1 (R0 is defined as no macroscopic residual disease, R1 is defined as macroscopic residual disease with a maximal diameter of \<1 cm)
• Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization
• Laboratory criteria:
‣ 1. White blood cells \>4000/mm3 (4.0×109/L) 5.2. Neutrophil count \>1500/mm3 (1.5×109/L) 5.3. Hemoglobin ≥8 g/dL (80 g/L) 5.4. Platelet count ≥100,000/mm3 (100×109/L) 5.5. Total bilirubin \<2× upper limit of normal (ULN) (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted) 5.6. Serum alanine aminotransferase, aspartate aminotransferase, and creatinine \<2×ULN 5.7. Blood urea nitrogen \<2×ULN
• Adequate coagulation parameters:
‣ 1. Activated partial thromboplastin time ≤1.5×ULN 6.2. International normalized ratio ≤1.5
• ECOG performance status 0-2
• Patients of child-bearing potential and their partners who are sexually active must agree to the use of 2 highly effective forms of contraception from the patient's signing of the ICF until 6 months after the last/final dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later:
• a. Condom with spermicide and one of the following:
⁃ Oral contraceptive or hormonal therapy (e.g., hormone implants)
⁃ Placement of an intra-uterine device (IUD)
• Acceptable non-hormonal birth control methods include:
‣ Total sexual abstinence from the patient's signing of the ICF until 6 months after the last/final dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later
‣ Vasectomized sexual partner plus male condom with spermicide and participant assurance that partner received post-vasectomy confirmation of azoospermia
‣ Tubal occlusion plus male condom with spermicide
‣ IUD plus male condom with spermicide. Provided coils are copper-banded.
• Acceptable hormonal methods include:
‣ Etonogestrel implants (e.g., Implanon, Norplan) plus male condom with spermicide
‣ Normal and low dose combined oral pills plus male condom with spermicide
‣ Norelgestromin/ethinyl estradiol transdermal system plus male condom with spermicide
‣ Intravaginal device plus male condom with spermicide (e.g., ethinyl estradiol and etonogestrel)
‣ Cerazette (desogestrel) plus male condom with spermicide. Cerazette is currently the only highly efficacious progesterone-based pill.
• Signed informed consent and ability to comprehend its content