A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
This is a Phase 3 study of AVB-S6-500 in combination with paclitaxel (Pac) in patients with platinum-resistant recurrent ovarian cancer. This is a randomized, double-blind, placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination with Pac versus placebo plus Pac.
- Experimental: AVB-S6-500+Paclitaxel
- Placebo Comparator: Placebo+Paclitaxel
- Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- Aged 18 years or older
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
- Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).
- Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
- Received at least 1 but not more than 4 prior therapy regimens. Note: maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
- Measurable disease according to RECIST v1.1 criteria