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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06428409
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab tirumotecan — BIOLOGICAL
    Given by IV infusion.
  • Fluorouracil (5-FU) — DRUG
    5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
  • Leucovorin (LV) or levoleucovorin — DRUG
    LV or levoleucovorin is administered by IV infusion every 2 weeks.
  • Rescue medication — DRUG
    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 — DRUG
    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 — DRUG
    Given by IV infusion.
  • Pembrolizumab — BIOLOGICAL
    Given by IV infusion.

Study Details

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

Key Dates

Start date
Jun 20, 2024
Status verified
Jan 2026
Primary completion
Oct 16, 2029
Completion
Oct 16, 2029

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants Who Experience a Dose-limiting Toxicity (DLT) [ Time Frame: Up to approximately 4 weeks ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
UCLA ( Site 0317)Los AngelesCalifornia90095
Study Coordinator
310-633-8400
University of Colorado Anschutz Medical Campus ( Site 0299)AuroraColorado80045
Study Coordinator
303-724-8644
University of Colorado Anschutz Medical Campus ( Site 0325)AuroraColorado80045
Study Coordinator
720-848-0300
University of Colorado Anschutz Medical Campus ( Site 0326)AuroraColorado80045
Study Coordinator
720-848-0300
Sibley Memorial Hospital ( Site 0310)Washington D.C.District of Columbia20016
Study Coordinator
202-660-6500
University of Florida College of Medicine ( Site 0281)GainesvilleFlorida32610
Study Coordinator
352-265-5121
Mount Sinai Cancer Center ( Site 0287)Miami BeachFlorida33140
Study Coordinator
305-674-2625
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)MariettaGeorgia30060-
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)MineolaNew York11501
Study Coordinator
646-599-4083
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)New YorkNew York10016
Study Coordinator
212-731-6000
University of Texas MD Anderson Cancer Center ( Site 0316)HoustonTexas77030
Study Coordinator
713-792-2828
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)RoanokeVirginia24014
Study Coordinator
540-491-2240
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)MadisonWisconsin53792
Study Coordinator
800-622-8922

Find similar trials in Los Angeles, CA

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
UCLA· Los Angeles, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COSibley Memorial Hospital· Washington D.C., DCUniversity of Florida College of Medicine· Gainesville, FLMount Sinai Cancer Center· Miami Beach, FLNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital· Marietta, GA

Related Studies