a study to compare sacituzumab tirumotecan (mk-2870) monotherapy versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer (mk-2870-020/trofuse-020/gog-3101/engot-cx20)

Conditions: Cervical Cancer

Summary: 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.


Eligibility criteria:
inclusion criteria: * has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix * must have 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) and must have received anti-pd-1/anti-pd-l1 therapy as part of prior cervical cancer regimens * has measurable disease per response evaluation criteria in solid tumors (recist) 1.1, as assessed by the investigator. lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions * is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent * has ecog performance status of 0 or 1 within 7 days before allocation for the sacituzumab tirumotecan run-in or within 7 days before randomization for the phase 3 portion * has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated * hiv-infected participants must have well controlled human immunodeficiency virus (hiv) on antiretroviral therapy (art) * participants who are hepatitis b surface antigen (hbsag) positive are eligible if they have received hepatitis b virus (hbv) antiviral therapy for at least 4 weeks, and have undetectable hbv viral load prior to allocation (sacituzumab tirumotecan run-in) or randomization (phase 3 portion) * participants with history of hepatitis c virus (hcv) infection are eligible if hcv viral load is undetectable at screening * has adequate organ function exclusion criteria: * has grade ≥2 peripheral neuropathy * has history of documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or severe 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. * received prior systemic anticancer therapy * received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. administration of killed vaccines is allowed * has histological subtypes of cervical cancer other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma) or nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) * known additional malignancy that is progressing or has required active treatment within the past 3 years * known active central nervous system (cns) metastases and/or carcinomatous meningitis * active infection requiring systemic therapy * hiv-infected participants with a history of kaposi's sarcoma and/or multicentric castleman's disease * concurrent active hepatitis b and active hepatitis c virus infection * severe hypersensitivity (≥grade 3) to sacituzumab tirumotecan or treatment of physician's choice (tpc) and/or any of their excipients, or other biologic therapy * participants who have not adequately recovered from major surgery or have ongoing surgical complications * has a history of (noninfectious) pneumonitis/ild that required steroids or has current pneumonitis/ild