Esophageal Cancer Clinical Trial

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

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a histologically-or cytologically-confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma.
Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens.
Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab.
Has adequate organ function.
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 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 measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology.
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.

Exclusion Criteria:

Has experienced weight loss >20% over 3 months before the first dose of study intervention.
Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or 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 a trophoblast antigen 2(TROP2) targeted antibody-drug conjugate (ADC), a topoisomerase 1 inhibitor based, 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 the study. The required washout period before starting sacituzumab tirumotecan 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 CNS metastases and/or carcinomatous meningitis.- Has an active infection requiring systemic therapy.
Has a history of human immunodeficiency virus (HIV) infection.- Has concurrent active hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive and/or detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and/or hepatitis C (defined as anti-hepatitis C virus (HCV) antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection or a known history of hepatitis B and/or C infection.
Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention.
Has severe hypersensitivity (Grades >=3) to sacituzumab tirumotecan, any of its excipients, and/or to another biologic therapy.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT06356311

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 9 Locations for this study

See Locations Near You

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108)
Marietta Georgia, 30060, United States More Info
Study Coordinator
Contact
770-281-5100
Rambam Health Care Campus-Oncology Division ( Site 1600)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247776700
Sourasky Medical Center ( Site 1602)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
97236973082
Seoul National University Bundang Hospital ( Site 3504)
Seongnam Kyonggi-do, 13620, Korea, Republic of More Info
Study Coordinator
Contact
821041671676
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3500)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
82222288050
Asan Medical Center-Department of Oncology ( Site 3501)
Seoul , 05505, Korea, Republic of More Info
Study Coordinator
Contact
82230105935
Samsung Medical Center-Division of Hematology/Oncology ( Site 3502)
Seoul , 06351, Korea, Republic of More Info
Study Coordinator
Contact
+82-2-3410-6820
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3505)
Seoul , 06591, Korea, Republic of More Info
Study Coordinator
Contact
01090566116
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3604)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
886623535354559

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT06356311

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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