Recruiting

Phase 1

Phase 2

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06428409

Conditions

Colorectal Cancer

Pancreatic Ductal Adenocarcinoma

Biliary Tract Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Fluorouracil (5-FU)

Leucovorin (LV) or levoleucovorin

Rescue medication

Supportive care measures

Study Details

Brief 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

Conditions

Colorectal Cancer

Pancreatic Ductal Adenocarcinoma

Biliary Tract Cancer

Study ID

NCT06428409

Start date

Jun 20, 2024

Status verified date

Oct, 2026

Completion date

Oct 16, 2029

Anticipated

Primary completion date

Oct 16, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening

Study Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sacituzumab tirumotecan + Chemotherapy

Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.

experimental: Sacituzumab tirumotecan

Participants will receive sacituzumab tirumotecan in one of two dose levels every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.

experimental: Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.

Interventions

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.

Primary outcome measure

Number of Participants Who Experience a Dose-limiting Toxicity (DLT) [ Time Frame: Up to approximately 4 weeks ]
Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 63 months ]
Number of Participants who Discontinue Study Treatment due to an AE [ Time Frame: Up to approximately 63 months ]
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 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

UCLA ( Site 0317)

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

310-633-8400

University of Colorado Anschutz Medical Campus ( Site 0299)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

303-724-8644

University of Colorado Anschutz Medical Campus ( Site 0325)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-848-0300

University of Colorado Anschutz Medical Campus ( Site 0326)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-848-0300

Sibley Memorial Hospital ( Site 0310)

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Study Coordinator

202-660-6500

University of Florida College of Medicine ( Site 0281)

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Study Coordinator

352-265-5121

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)

Recruiting

Mineola, New York, United States, 11501

Contacts

Study Coordinator

646-599-4083

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

212-731-6000

University of Texas MD Anderson Cancer Center ( Site 0316)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-792-2828

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Study Coordinator

540-491-2240

University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Study Coordinator

800-622-8922

The Ottawa Hospital Cancer Centre ( Site 0027)

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Study Coordinator

613-737-7700 x70185

Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Study Coordinator

5148908000

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.