A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06428409
This study evaluates the safety and efficacy of sacituzumab tirumotecan, alone or with chemotherapy, in treating advanced or unresectable GI cancers. Eligible participants have specific GI cancers and have undergone prior therapy. Interventions include sacituzumab tirumotecan, 5-FU, leucovorin, rescue medications, and supportive care to manage treatment-related adverse events.
Patient Parameters
| Parameter | Options |
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Program Overview
Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:
- About the safety and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy
- How many people have the cancer respond (get smaller or go away) to treatment
Eligibility Criteria
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
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Has one of the following cancers:
- Unresectable or metastatic colorectal cancer
- Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
- Advanced and/or unresectable biliary tract cancer (BTC)
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Has received prior therapy for the cancer
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Has recovered from any side effects due to previous cancer treatment
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
- History of severe eye disease
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA ( Site 0317) | 90095 | Los Angeles | California |
| Sibley Memorial Hospital ( Site 0310) | 20016 | Washington | District of Columbia |
| University of Florida College of Medicine ( Site 0281) | 32610 | Gainesville | Florida |
| Mount Sinai Cancer Center ( Site 0287) | 33140 | Miami Beach | Florida |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303) | 30060 | Marietta | Georgia |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327) | 11501 | Mineola | New York |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324) | 10016 | New York | New York |
| University of Texas MD Anderson Cancer Center ( Site 0316) | 77030 | Houston | Texas |
| Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295) | 24014 | Roanoke | Virginia |
| University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293) | 53792 | Madison | Wisconsin |
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