NCT06428409 · Merck Sharp & Dohme LLC
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
What this study is about
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).
View original scientific description
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).
Interventions
BIOLOGICAL
Sacituzumab tirumotecan
Given by IV infusion.
DRUG
Fluorouracil (5-FU)
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
DRUG
Leucovorin (LV) or levoleucovorin
LV or levoleucovorin is administered by IV infusion every 2 weeks.
DRUG
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.
DRUG
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.
DRUG
Cisplatin
Given by IV infusion.
BIOLOGICAL
Pembrolizumab
Given by IV infusion.
Primary outcome measures
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The main inclusion criteria include but are not limited to the following:
- Has one of the following cancers:
- Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer
- Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
- Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
- Advanced and/or unresectable BTC and has not received prior therapy for the cancer
- For participants who have received prior therapy for cancer: 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
- For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
- History of (no
Where
- Los Angeles, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Gainesville, Florida
- Miami Beach, Florida
- Marietta, Georgia
- Mineola, New York
- New York, New York
- Houston, Texas
- Roanoke, Virginia
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations