Last updated 19 days ago
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)
686 patients around the world
Available in Puerto Rico, Argentina, United States
Merck Sharp & Dohme LLC
1Research sites
686Patients around the world
This study is for people with
Cervical cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- 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.
- 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.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 histologically-confirmed diagnosis of glassy cell carcinoma variant, adenoid cystic carcinoma, adenoid basal carcinoma, neuroendocrine tumors, carcinoid, atypical carcinoid, small-carcinoma, large-cell neuroendocrine carcinoma, or undifferentiated carcinoma.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.
Sites
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
StudyMK-2870-020
SponsorMerck Sharp & Dohme LLC
Conditions
Cervical cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT06459180
