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)
Cervical CancerThis 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.
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Participation Requirements
-
Sex:
FEMALE -
Eligible Ages:
18 and up
Participation 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 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
* Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
Study Location
McGill University Health Centre ( Site 4000)
McGill University Health Centre ( Site 4000)Montreal, Quebec
Canada
Contact Study Team
Study Coordinator
514-934-1934 ext. 34049Centre Hospitalier de l'Université de Montréal ( Site 4001)
Centre Hospitalier de l'Université de Montréal ( Site 4001)Montréal, Quebec
Canada
Contact Study Team
Study Coordinator
514-890-8000Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4Quebec City, Quebec
Canada
Contact Study Team
Study Coordinator
4182558841BC Cancer Surrey ( Site 4006)
BC Cancer Surrey ( Site 4006)Surrey, British Columbia
Canada
Contact Study Team
Study Coordinator
1-888-577-8839BC Cancer Kelowna ( Site 4007)
BC Cancer Kelowna ( Site 4007)Kelowna, British Columbia
Canada
Contact Study Team
Study Coordinator
1-888-577-8839BC Cancer Victoria ( Site 4008)
BC Cancer Victoria ( Site 4008)Victoria, British Columbia
Canada
Contact Study Team
Study Coordinator
1-888-577-8839- Study Sponsored By
- Merck Sharp & Dohme LLC
- Participants Required
- More Information
- Study ID:
NCT06459180