ACTIVE_NOT_RECRUITING

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

Conditions

Gastroesophageal Cancer Gastroesophageal adenocarcinoma Gastric adenocarcinoma Esophageal adenocarcinoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician's Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)

Quick Facts

Study Start:2024-05-03

Study Completion:2027-05-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06356311

Participation Criteria

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 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 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	* 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 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 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 hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection * 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 severe hypersensitivity (Grades \>=3) to the study interventions, any of their excipients, and/or to another biologic therapy * Has a history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD

Inclusion Criteria

Exclusion Criteria

* 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 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 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

* 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 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 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 hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
* 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 severe hypersensitivity (Grades \>=3) to the study interventions, any of their excipients, and/or to another biologic therapy
* Has a history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Banner MD Anderson Cancer Center ( Site 0119)

Gilbert, Arizona, 85234

United States

UCLA Hematology/Oncology - Santa Monica ( Site 0140)

Los Angeles, California, 90404

United States

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129)

Orlando, Florida, 32804

United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108)

Marietta, Georgia, 30060

United States

University of Chicago Medical Center ( Site 0120)

Chicago, Illinois, 60637

United States

University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124)

Lexington, Kentucky, 40536

United States

The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113)

Louisville, Kentucky, 40202

United States

Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105)

Louisville, Kentucky, 40217

United States

Henry Ford Hospital ( Site 0107)

Detroit, Michigan, 48202

United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138)

Fargo, North Dakota, 58122

United States

Oregon Health and Science University ( Site 0104)

Portland, Oregon, 97239

United States

UPMC Hillman Cancer Center ( Site 0126)

Pittsburgh, Pennsylvania, 15232

United States

MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122)

Charleston, South Carolina, 29425

United States

Sanford Cancer Center ( Site 0136)

Sioux Falls, South Dakota, 57104

United States

The West Clinic, PLLC dba West Cancer Center ( Site 0110)

Germantown, Tennessee, 38138

United States

Inova Schar Cancer ( Site 0106)

Fairfax, Virginia, 22031

United States

Fred Hutchinson Cancer Center ( Site 0111)

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03

Study Completion Date2027-05-06

Study Record Updates

Study Start Date2024-05-03

Study Completion Date2027-05-06

Terms related to this study

Keywords Provided by Researchers

Gastroesophageal cancer
Gastroesophageal adenocarcinoma
Gastric adenocarcinoma
Esophageal adenocarcinoma

Additional Relevant MeSH Terms

Gastroesophageal Cancer