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NCT06428409PHASE1, PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

6/20/2024

Completion Date

10/16/2029

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

DRUG

Fluorouracil (5-FU)

DRUG

Leucovorin (LV) or levoleucovorin

DRUG

Rescue medication

DRUG

Supportive care measures

DRUG

Cisplatin

BIOLOGICAL

Pembrolizumab

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Conditions

Colorectal CancerPancreatic Ductal AdenocarcinomaBiliary Tract Cancer

Locations

UCLA ( Site 0317)

Los Angeles, California 90095

United States

University of Colorado Anschutz Medical Campus ( Site 0299)

Aurora, Colorado 80045

United States

University of Colorado Anschutz Medical Campus ( Site 0325)

Aurora, Colorado 80045

United States

University of Colorado Anschutz Medical Campus ( Site 0326)

Aurora, Colorado 80045

United States

Sibley Memorial Hospital ( Site 0310)

Washington D.C., District of Columbia 20016

United States

University of Florida College of Medicine ( Site 0281)

Gainesville, Florida 32610

United States

Mount Sinai Cancer Center ( Site 0287)

Miami Beach, Florida 33140

United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)

Marietta, Georgia 30060

United States

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

Mineola, New York 11501

United States

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

New York, New York 10016

United States

University of Texas MD Anderson Cancer Center ( Site 0316)

Houston, Texas 77030

United States

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

Roanoke, Virginia 24014

United States

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

Madison, Wisconsin 53792

United States

Westmead Hospital ( Site 0003)

Westmead, New South Wales 2145

Australia

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)

Brisbane, Queensland 4029

Australia

Epworth Freemasons ( Site 0005)

East Melbourne, Victoria 3002

Australia

Frankston Hospital-Oncology and Haematology ( Site 0004)

Frankston, Victoria 3199

Australia

One Clinical Research ( Site 0002)

Nedlands, Western Australia 6009

Australia

The Ottawa Hospital Cancer Centre ( Site 0027)

Ottawa, Ontario K1H 8L6

Canada

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

Montreal, Quebec H2X 0A9

Canada

McGill University Health Centre ( Site 0023)

Montreal, Quebec H4A 3J1

Canada

James Lind Centro de Investigacion del Cancer ( Site 0048)

Temuco, Araucania 4800827

Chile

FALP-UIDO ( Site 0041)

Providencia, Region M. de Santiago 7500921

Chile

Clínica UC San Carlos de Apoquindo ( Site 0043)

Santiago, Region M. de Santiago 7620002

Chile

Bradfordhill-Clinical Area ( Site 0047)

Santiago, Region M. de Santiago 8420383

Chile

Beijing Cancer hospital-Digestive Oncology ( Site 0061)

Beijing, Beijing Municipality 100142

China

The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)

Fuzhou, Fujian 350025

China

Wuhan Union Hospital Cancer Center. ( Site 0064)

Wuhan, Hubei 430024

China

Hunan Cancer Hospital-intervention department ( Site 0066)

Changsha, Hunan 410013

China

Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)

Shanghai, Shanghai Municipality 200127

China

West China Hospital, Sichuan University ( Site 0068)

Chengdu, Sichuan 610041

China

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)

Milan, Lombardy 20133

Italy

ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)

Milan, Lombardy 20162

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)

Roma, 00168

Italy

National Cancer Center Hospital East ( Site 0121)

Kashiwa, Chiba 277-8577

Japan

Kanagawa Cancer Center ( Site 0122)

Yokohama, Kanagawa 241-8515

Japan

Seoul National University Hospital ( Site 0161)

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System ( Site 0164)

Seoul, 03722

South Korea

Asan Medical Center ( Site 0163)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 0162)

Seoul, 06351

South Korea

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)

Madrid, Madrid, Comunidad de 28009

Spain

Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)

Oviedo, Principality of Asturias 33011

Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)

Barcelona, 08035

Spain

Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

Geneva, Canton of Geneva 1211

Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 0201)

Bellinzona, Canton Ticino 6500

Switzerland

China Medical University Hospital ( Site 0223)

Taichung, 404332

Taiwan

National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)

Tainan, 704

Taiwan

National Taiwan University Hospital-Oncology ( Site 0225)

Taipei, 10002

Taiwan

Taipei Veterans General Hospital ( Site 0221)

Taipei, 112

Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0222)

Taoyuan, 33305

Taiwan

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)

Ankara, 06230

Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)

Ankara, 06800

Turkey (Türkiye)

Barts Health NHS Trust ( Site 0263)

London, England E1 1RD

United Kingdom

Royal Free Hospital ( Site 0262)

London, England NW3 2QG

United Kingdom

University Hospital Coventry & Warwickshire ( Site 0266)

Coventry, CV2 2DX

United Kingdom