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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Biological: Sacituzumab tirumotecan
    Given by IV infusion.
    Other names:
    • MK-2870
    • SKB264
  • 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.
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.
  • Biological: Sacituzumab tirumotecan
    Given by IV infusion.
    Other names:
    • MK-2870
    • SKB264
  • 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.
    Other names:
    • PLATINOL®
  • Biological: Pembrolizumab
    Given by IV infusion.
    Other names:
    • MK-3475
    • KEYTRUDA®
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.
  • Biological: Sacituzumab tirumotecan
    Given by IV infusion.
    Other names:
    • MK-2870
    • SKB264
  • 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.
    Other names:
    • PLATINOL®
  • Biological: Pembrolizumab
    Given by IV infusion.
    Other names:
    • MK-3475
    • KEYTRUDA®

Recruiting Locations

UCLA ( Site 0317)
Los Angeles, California 90095
Contact:
Study Coordinator
310-633-8400

University of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado 80045
Contact:
Study Coordinator
303-724-8644

University of Colorado Anschutz Medical Campus ( Site 0325)
Aurora, Colorado 80045
Contact:
Study Coordinator
720-848-0300

University of Colorado Anschutz Medical Campus ( Site 0326)
Aurora, Colorado 80045
Contact:
Study Coordinator
720-848-0300

Sibley Memorial Hospital ( Site 0310)
Washington D.C., District of Columbia 20016
Contact:
Study Coordinator
202-660-6500

University of Florida College of Medicine ( Site 0281)
Gainesville, Florida 32610
Contact:
Study Coordinator
352-265-5121

Mount Sinai Cancer Center ( Site 0287)
Miami Beach, Florida 33140
Contact:
Study Coordinator
305-674-2625

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
Mineola, New York 11501
Contact:
Study Coordinator
646-599-4083

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
New York, New York 10016
Contact:
Study Coordinator
212-731-6000

University of Texas MD Anderson Cancer Center ( Site 0316)
Houston, Texas 77030
Contact:
Study Coordinator
713-792-2828

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
Roanoke, Virginia 24014
Contact:
Study Coordinator
540-491-2240

University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
Madison, Wisconsin 53792
Contact:
Study Coordinator
800-622-8922

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.