GOG-3103 (TroFuse-022/MK2870-022): OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SACITUZUMAB TIRUMOTECAN MAINTENANCE TREATMENT WITH/WITHOUT BEVACIZUMAB VERSUS SOC AFTER SECOND LINE PLATINUM-BASED DOUBLET CHEMO IN PTS WITH PLATINUM-SENSITIVE RECURRENT OVARIAN CANCER

Inclusion:  

***NOTE: Tissue must be submitted centrally for TROP2 testing (22-29 BUSINESS DAY TURN AROUND TIME)

• Locally adv or met Epithelial (high-grade serous, high-grade grade endometrioid, MMMT with high-grade serous component, clear cell) ovarian cancer.  Tumors classified as Grade 2 may be enrolled if >50% Grade 3 features are present.

• Received 4+ cycle of platinum-based doublet chemo in first line and a total of 6-8 cycles of carboplatin-based doublet chemo in second line setting (*at least 2 doses of bev is required in 2nd line* if intention is to use bev in maintenance for trial; and will be required for those pts that have SD after chemo, otherwise those pts will be inelig)

• Enrollment of pts who d/c carboplatin-based doublet chemo in 2nd line setting due to toxicity after receiving 4-5 cycles may be permitted after review with sponsor

• Second-line doublet chemotherapy must have included 1 of the following combinations: 

• - Carboplatin AUC5 on Day 1 plus paclitaxel 175 mg/m² on Day 1 q3w 

•  Carboplatin AUC4 on Day 1 plus gemcitabine 1000 mg/m² on Days 1 and 8 q3w 

• Carboplatin AUC5 on Day 1 plus pegylated liposomal doxorubicin 30 mg/m² on Day 1 q4w

• Interval between the last dose of second line chemo rando must be ≤10 weeks

• May have received prior anti-PD-1/PD-L1, bevacizumab or iPARP

• Platinum-sensitive disease (PD ˃180 days) after the last dose of first line platinum-based chemo

• Has NED, CR, PR, or SD at the time of screening (CT 3-8 weeks after last dose of platinum chemo)

• Pts with a response of SD must be eligible to receive bevacizumab

• iPARP is not the preferred 2nd line treatment per the investigator

• Pts with known BRCAm/HRD + who were CR/PR/NED after first line chemo must have previously received iPARP as first line maintenance

Exclusion:

• Active/ongoing stomatitis