Status:
RECRUITING
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GOG Foundation
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2028
Estimated Enrollment :
686 Patients enrolled
Trial Details
Trial ID
NCT06459180
Start Date
July 24 2024
End Date
June 15 2028
Last Update
March 13 2026
Active Locations (239)
Enter a location and click search to find clinical trials sorted by distance.
1
USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
Mobile, Alabama, United States, 36604
2
Providence Alaska Medical Center ( Site 4137)
Anchorage, Alaska, United States, 99508
3
HonorHealth (HH) ( Site 8002)
Phoenix, Arizona, United States, 85016
4
Arizona Oncology Associates - HOPE ( Site 8001)
Tucson, Arizona, United States, 85711