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Be Part of Research - Trial Details - A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)

A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Biliary Tract Neoplasms
Gastrointestinal Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2024 Oct 2029

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Given by IV infusion every 2 weeks (Day 1 and Day 15 of every 4-week cycle)

Intervention Arm Group : Sacituzumab tirumotecan;Sacituzumab tirumotecan + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks

Intervention Arm Group : Sacituzumab tirumotecan + Chemotherapy;

Intervention Type : DRUG
Intervention Description : LV or levoleucovorin is administered by IV infusion every 2 weeks

Intervention Arm Group : Sacituzumab tirumotecan + Chemotherapy;

Intervention Type : DRUG
Intervention Description : Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

Intervention Arm Group : Sacituzumab tirumotecan;Sacituzumab tirumotecan + Chemotherapy;

Intervention Type : DRUG
Intervention Description : Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.

Intervention Arm Group : Sacituzumab tirumotecan;Sacituzumab tirumotecan + Chemotherapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Barts Health NHS Trust ( Site 0263)
    London
    England
    E1 1RD
  • University Hospital Coventry & Warwickshire ( Site 0266)
    Coventry
    CV2 2DX
  • Royal Free Hospital ( Site 0262)
    London
    England
    NW3 2QG


The study is sponsored by Merck Sharp & Dohme LLC




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Read full details for Trial ID: NCT06428409
Last updated 15 May 2025

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