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

Condition(s) studied

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecan: Given by IV infusion.

Fluorouracil (5-FU): 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.

Leucovorin (LV) or levoleucovorin: LV or levoleucovorin is administered by IV infusion every 2 weeks.

Rescue medication: Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[H1\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

Supportive care measures: 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 supportive care for Ocular Surface Toxicity.

Cisplatin: Given by IV infusion.

Pembrolizumab: Given by IV infusion.

Study summary

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments 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 of sacituzumab tirumotecan alone or with other treatments and if people tolerate it
* How many people have the cancer respond (get smaller or go away) to treatment

Eligibility

Primary outcome measure(s)

• Number of Participants Who Experience a Dose-limiting Toxicity (DLT) — Up to approximately 4 weeks
  A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
• Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 63 months
  An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
• Number of Participants who Discontinue Study Treatment due to an AE — Up to approximately 63 months
  An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 63 months
  ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Trial sites (55)

+ 15 more sites — see the full list on the official registry below.

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