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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)

NCT06459180

Active Not RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Cervical Cancer

Interventions: Sacituzumab Tirumotecan, Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix.
* 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

Locations (240)

Mobile, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Savannah, Georgia, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Reno, Nevada, United States
Teaneck, New Jersey, United States
Albuquerque, New Mexico, United States
Mineola, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Hilliard, Ohio, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Germantown, Tennessee, United States
Austin, Texas, United States
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