Study

Overview

Official Title: A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (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 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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

686

Study Start Date:

July 2024

Estimated Study Completion Date:

June 2028

Estimated Primary Completion Date:

June 2028

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

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 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

Locations

United States Toll Free Number 1-800-770-4674

San Juan, 00935
Mobile, Alabama, 36604
Anchorage, Alaska, 99508
Phoenix, Arizona, 85016
La Jolla, California, 92093
Los Angeles, California, 90095
Newport Beach, California, 92663
Miami Beach, Florida, 33140
Orlando, Florida, 32804
West Palm Beach, Florida, 33401
Savannah, Georgia, 31405
New Orleans, Louisiana, 70112
Shreveport, Louisiana, 71103
Reno, Nevada, 89511
Teaneck, New Jersey, 07666
Albuquerque, New Mexico, 87109
Mineola, New York, 11501
New York, New York, 10016
Durham, North Carolina, 27710
Cincinnati, Ohio, 45219
Hilliard, Ohio, 43026
Tulsa, Oklahoma, 74146
Eugene, Oregon, 97401
Portland, Oregon, 97210
Philadelphia, Pennsylvania, 19107
Willow Grove, Pennsylvania, 19090
Germantown, Tennessee, 38138
Austin, Texas, 78731
Fort Worth, Texas, 76104
Houston, Texas, 77030
San Antonio, Texas, 78240
Tyler, Texas, 75702
Webster, Texas, 77598
Charlottesville, Virginia, 22908
Fairfax, Virginia, 22031-4867
Seattle, Washington, 98104

Canada Study Coordinator 604-930-2098

Results

No Study Results Posted

Study Detail

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)

Overview

Eligibility

CRITERIA

Locations

Results