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NCT06459180 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Cervical Cancer, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
686
Enrollment target
20
Study locations

NCT06459180: Recruiting Phase 3 study of Cervical Cancer, sponsored by Merck Sharp & Dohme.

NCT06459180 is a Phase 3 study of Cervical Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 686 participants, above the 566-participant average among 144 other Cervical Cancer trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06459180, a Phase 3 study of Cervical Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
686 participants
Enrollment target
20
Study locations

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.

Primary Outcome

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Conditions Studied

Cervical Cancer

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

FieldValue
Enrollment Target 686 participants
Start Date 2024-07-24
Est. Completion 2028-06-15
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What NCT06459180 shows while recruiting

NCT06459180 is an interventional study that assigns participants to a tested intervention. The registered 686 participants enrollment target is mid-sized for trials with a published cap, above the 566-participant average among 144 other Cervical Cancer trials with a reported enrollment target (21% higher).

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.

NCT06459180 names 20 study sites across 11 states, led by California, Florida, Georgia.

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.

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).

Who is sponsoring clinical trial NCT06459180?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Cervical Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06459180's enrollment target sits among peer trials

686 21st of 144 higher than 124 of 144 other Cervical Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cervical Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06459180

Source: ClinicalTrials.gov NCT06459180, the US trial registry maintained by the National Library of Medicine. NCT06459180 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.