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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 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Pemetrexed
- DRUG Topotecan
- BIOLOGICAL Sacituzumab Tirumotecan
- DRUG Vinorelbine
- BIOLOGICAL Tisotumab Vedotin
Study Locations (20)
California
- Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125) — La Jolla
- UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105) — Los Angeles
- Hoag Memorial Hospital Presbyterian ( Site 4104) — Newport Beach
Florida
- Mount Sinai Comprehensive Cancer Center ( Site 4143) — Miami Beach
- Advent Health ( Site 4140) — Orlando
- Florida Cancer Specialists East ( Site 7001) — West Palm Beach
Georgia
- Northside Hospital ( Site 4127) — Atlanta
- Georgia Cancer Center at Augusta University ( Site 4112) — Augusta
- Lewis Cancer and Research Pavilion ( Site 4114) — Savannah
Arizona
- HonorHealth (HH) ( Site 8002) — Phoenix
- Arizona Oncology Associates - HOPE ( Site 8001) — Tucson
Louisiana
- University Medical Center New Orleans ( Site 4132) — New Orleans
- Willis Knighton Medical Center ( Site 4101) — Shreveport
New York
- Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145) — Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121) — New York
Alabama
- USA Mitchell Cancer Institute-Clinical Trials ( Site 4126) — Mobile
Alaska
- Providence Alaska Medical Center ( Site 4137) — Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 686 participants |
| Start Date | 2024-07-24 |
| Est. Completion | 2028-06-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06459180
The ClinicalTrials.gov registry entry for NCT06459180 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 686 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cervical Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pemetrexed is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06459180 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06459180 about?
NCT06459180 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT06459180?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 686 participants. The study started on 2024-07-24. Estimated completion is 2028-06-15.
What conditions does trial NCT06459180 study?
This clinical trial studies the following conditions: Cervical Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06459180?
The interventions under investigation include: Pemetrexed (DRUG), Topotecan (DRUG), Sacituzumab Tirumotecan (BIOLOGICAL), Vinorelbine (DRUG), Tisotumab Vedotin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06459180?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06459180 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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