A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
NCT ID: NCT06428409
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2024-06-20
2029-10-16
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Sacituzumab tirumotecan
Given by IV infusion.
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.
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.
Sacituzumab tirumotecan
Given by IV infusion.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 that required steroids or has current pneumonitis/interstitial lung disease
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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UCLA ( Site 0317)
Los Angeles, California, United States
University of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus ( Site 0325)
Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus ( Site 0326)
Aurora, Colorado, United States
Sibley Memorial Hospital ( Site 0310)
Washington D.C., District of Columbia, United States
University of Florida College of Medicine ( Site 0281)
Gainesville, Florida, United States
Mount Sinai Cancer Center ( Site 0287)
Miami Beach, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
Marietta, Georgia, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
New York, New York, United States
University of Texas MD Anderson Cancer Center ( Site 0316)
Houston, Texas, United States
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
Roanoke, Virginia, United States
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
Madison, Wisconsin, United States
Westmead Hospital ( Site 0003)
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0005)
East Melbourne, Victoria, Australia
Frankston Hospital-Oncology and Haematology ( Site 0004)
Frankston, Victoria, Australia
One Clinical Research ( Site 0002)
Nedlands, Western Australia, Australia
The Ottawa Hospital Cancer Centre ( Site 0027)
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0023)
Montreal, Quebec, Canada
FALP-UIDO ( Site 0041)
Providencia, Region M. de Santiago, Chile
Clínica UC San Carlos de Apoquindo ( Site 0043)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0047)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 0048)
Temuco, Región de la Araucanía, Chile
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
Beijing, Beijing Municipality, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
Fuzhou, Fujian, China
Wuhan Union Hospital Cancer Center. ( Site 0064)
Wuhan, Hubei, China
Hunan Cancer Hospital-intervention department ( Site 0066)
Changsha, Hunan, China
Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 0068)
Chengdu, Sichuan, China
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
Milan, Lombardy, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
Roma, , Italy
National Cancer Center Hospital East ( Site 0121)
Kashiwa, Chiba, Japan
Kanagawa Cancer Center ( Site 0122)
Yokohama, Kanagawa, Japan
Seoul National University Hospital ( Site 0161)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System ( Site 0164)
Seoul, , South Korea
Asan Medical Center ( Site 0163)
Seoul, , South Korea
Samsung Medical Center ( Site 0162)
Seoul, , South Korea
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
Barcelona, , Spain
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva, Canton of Geneva, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0201)
Bellinzona, Canton Ticino, Switzerland
China Medical University Hospital ( Site 0223)
Taichung, , Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
Tainan, , Taiwan
National Taiwan University Hospital-Oncology ( Site 0225)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0221)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
Taoyuan District, , Taiwan
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
Ankara, , Turkey (Türkiye)
Barts Health NHS Trust ( Site 0263)
London, England, United Kingdom
Royal Free Hospital ( Site 0262)
London, England, United Kingdom
University Hospital Coventry & Warwickshire ( Site 0266)
Coventry, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-9999-02A
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508703-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1298-8273
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031240178
Identifier Type: REGISTRY
Identifier Source: secondary_id
9999-02A
Identifier Type: -
Identifier Source: org_study_id