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.
Cervical Cancer
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.
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)
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UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc, Los Angeles, California, United States, 90095
University Medical Center New Orleans ( Site 4132), New Orleans, Louisiana, United States, 70112
Willis Knighton Medical Center ( Site 4101), Shreveport, Louisiana, United States, 71103
The Center of Hope ( Site 4106), Reno, Nevada, United States, 89511
Holy Name Medical Center ( Site 4117), Teaneck, New Jersey, United States, 07666
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116), Tulsa, Oklahoma, United States, 74146
Houston Methodist Hospital OB/GYN ( Site 4102), Houston, Texas, United States, 77030
University of Virginia Cancer Center ( Site 4123), Charlottesville, Virginia, United States, 22908
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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18 Years to
FEMALE
No
Merck Sharp & Dohme LLC,
Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC
2028-10-23