GOG-3101

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.

The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.

Inclusion Criteria

• Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
• Has recurrent or metastatic cervical cancer:
•     That has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab). Note: Participants may have also received prior chemoradiotherapy in the LACC setting; this is not considered a line of treatment.
•     Note: Any change in chemotherapy regimen (substitution or change in entire regimen) in the absence of clinical disease progression will be considered part of the same line of therapy.
• AND
•     Participants must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens. Note: prior treatment with IO/IO combination therapy eg, anti-PD-1/anti-PD-L1 with anti-CTLA4 therapy, is not allowed.
• Has measurable disease per RECIST 1.1, as assessed by the investigator.
• Has ECOG performance status of 0 or 1
• Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated.
• Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
• Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (MK-2870 Run-in) or randomization
• Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
• Has Grade ≥2 peripheral neuropathy.
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea). 
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to the start of study intervention.
• Received systemic therapy, including single-agent IO, in the second-line (or subsequent) setting.
• Received prior treatment with a TROP2-targeted ADC.
• Received prior treatment with any ADC for cervical cancer, including topoisomerase I inhibitor- or MMAE-containing ADCs.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.