A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

Running, not enrolling · Phase 3

Conditions studied: Gastroesophageal Cancer

In brief

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).

Key facts

Study ID

NCT06356311

Run by

Merck Sharp & Dohme LLC

People needed

450

Starts

2024-05-03

Expected to finish

2027-05-06

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a histologically or cytologically confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma
• Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
• Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens for advanced, unresectable or metastatic gastroesophageal adenocarcinoma
• Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab where available/appropriate
• Has provided tumor tissue sample for determination of trophoblast cell-surface antigen 2 (TROP2) status by the central laboratory before randomization for stratification
• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible
• Has adequate organ function
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days before randomization
• Has ability to swallow oral medication for those who may receive trifluridine-tipiracil
• Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
• Hepatitis B surface antigen (HBsAg)-positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
• Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

You may not qualify if…

• Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• Has Grade ≥2 peripheral neuropathy
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval (QTcF) to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention
• Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before the first dose of study intervention
• Has received prior treatment with TROP2-targeted antibody-drug conjugate (ADC), a topoisomerase 1 inhibitor-based ADC, and/or a topoisomerase 1 inhibitor-based chemotherapy
• Has received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention
• Has received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Is currently receiving a strong and/or moderate inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks
• Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active infection requiring systemic therapy
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castlemans's Disease
• Has concurrent active hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV (defined as anti-HCV antibody [Ab] positive and detectable HCV ribonucleic acid [RNA]) infection
• Has severe hypersensitivity (Grades >=3) to the study interventions, any of their excipients, and/or to another biologic therapy
• Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary
• Has a history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD

Where it is running

• UCLA Hematology/Oncology - Santa Monica ( Site 0140) — Los Angeles, California, United States
• AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129) — Orlando, Florida, United States
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108) — Marietta, Georgia, United States
• University of Chicago Medical Center ( Site 0120) — Chicago, Illinois, United States
• University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124) — Lexington, Kentucky, United States
• The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113) — Louisville, Kentucky, United States
• Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105) — Louisville, Kentucky, United States
• Henry Ford Hospital ( Site 0107) — Detroit, Michigan, United States
• Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138) — Fargo, North Dakota, United States
• Oregon Health and Science University ( Site 0104) — Portland, Oregon, United States
• UPMC Hillman Cancer Center ( Site 0126) — Pittsburgh, Pennsylvania, United States
• MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122) — Charleston, South Carolina, United States
• Sanford Cancer Center ( Site 0136) — Sioux Falls, South Dakota, United States
• The West Clinic, PLLC dba West Cancer Center ( Site 0110) — Germantown, Tennessee, United States
• Inova Schar Cancer ( Site 0106) — Fairfax, Virginia, United States
• Fred Hutchinson Cancer Center ( Site 0111) — Seattle, Washington, United States
• Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003) — Anderlecht, Bruxelles-Capitale, Region de, Belgium
• Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001) — Brussels, Bruxelles-Capitale, Region de, Belgium
• UZ Leuven-Digestive Oncology ( Site 1000) — Leuven, Vlaams-Brabant, Belgium
• AZ Delta vzw ( Site 1002) — Roeselare, West-Vlaanderen, Belgium
• Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 0405) — Fortaleza, Ceará, Brazil
• Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0406) — Natal, Rio Grande do Norte, Brazil
• Hospital de Caridade de Ijuí ( Site 0412) — Ijuí, Rio Grande do Sul, Brazil
• Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0400) — Porto Alegre, Rio Grande do Sul, Brazil
• Banner MD Anderson Cancer Center ( Site 0119) — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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