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

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

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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (55)

• UCLA ( Site 0317), Los Angeles, California · RECRUITING
• University of Colorado Anschutz Medical Campus ( Site 0299), Aurora, Colorado · RECRUITING
• University of Colorado Anschutz Medical Campus ( Site 0325), Aurora, Colorado · RECRUITING
• University of Colorado Anschutz Medical Campus ( Site 0326), Aurora, Colorado · RECRUITING
• Sibley Memorial Hospital ( Site 0310), Washington D.C., District of Columbia · RECRUITING
• University of Florida College of Medicine ( Site 0281), Gainesville, Florida · RECRUITING
• Mount Sinai Cancer Center ( Site 0287), Miami Beach, Florida · RECRUITING
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303), Marietta, Georgia · COMPLETED
• Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327), Mineola, New York · RECRUITING
• Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324), New York, New York · RECRUITING
• University of Texas MD Anderson Cancer Center ( Site 0316), Houston, Texas · RECRUITING
• Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295), Roanoke, Virginia · RECRUITING
• University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293), Madison, Wisconsin · RECRUITING
• Westmead Hospital ( Site 0003), Westmead, New South Wales, Australia · RECRUITING
• Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001), Brisbane, Queensland, Australia · RECRUITING
• Epworth Freemasons ( Site 0005), East Melbourne, Victoria, Australia · RECRUITING
• Frankston Hospital-Oncology and Haematology ( Site 0004), Frankston, Victoria, Australia · RECRUITING
• One Clinical Research ( Site 0002), Nedlands, Western Australia, Australia · RECRUITING
• The Ottawa Hospital Cancer Centre ( Site 0027), Ottawa, Ontario, Canada · RECRUITING
• Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022), Montreal, Quebec, Canada · RECRUITING
• McGill University Health Centre ( Site 0023), Montreal, Quebec, Canada · RECRUITING
• James Lind Centro de Investigacion del Cancer ( Site 0048), Temuco, Araucania, Chile · RECRUITING
• FALP-UIDO ( Site 0041), Providencia, Region M. de Santiago, Chile · RECRUITING
• Clínica UC San Carlos de Apoquindo ( Site 0043), Santiago, Region M. de Santiago, Chile · RECRUITING
• Bradfordhill-Clinical Area ( Site 0047), Santiago, Region M. de Santiago, Chile · RECRUITING
• Beijing Cancer hospital-Digestive Oncology ( Site 0061), Beijing, Beijing Municipality, China · RECRUITING
• The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063), Fuzhou, Fujian, China · RECRUITING
• Wuhan Union Hospital Cancer Center. ( Site 0064), Wuhan, Hubei, China · RECRUITING
• Hunan Cancer Hospital-intervention department ( Site 0066), Changsha, Hunan, China · RECRUITING
• Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067), Shanghai, Shanghai Municipality, China · RECRUITING
• West China Hospital, Sichuan University ( Site 0068), Chengdu, Sichuan, China · RECRUITING
• Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101), Milan, Lombardy, Italy · RECRUITING
• ASST Grande Ospedale Metropolitano Niguarda ( Site 0102), Milan, Lombardy, Italy · RECRUITING
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103), Roma, Italy · RECRUITING
• National Cancer Center Hospital East ( Site 0121), Kashiwa, Chiba, Japan · RECRUITING
• Kanagawa Cancer Center ( Site 0122), Yokohama, Kanagawa, Japan · RECRUITING
• Seoul National University Hospital ( Site 0161), Seoul, South Korea · RECRUITING
• Severance Hospital, Yonsei University Health System ( Site 0164), Seoul, South Korea · RECRUITING
• Asan Medical Center ( Site 0163), Seoul, South Korea · RECRUITING
• Samsung Medical Center ( Site 0162), Seoul, South Korea · RECRUITING
• HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183), Madrid, Madrid, Comunidad de, Spain · RECRUITING
• Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182), Oviedo, Principality of Asturias, Spain · RECRUITING
• Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181), Barcelona, Spain · RECRUITING
• Hôpitaux Universitaires de Genève (HUG) ( Site 0202), Geneva, Canton of Geneva, Switzerland · RECRUITING
• Ospedale Regionale Bellinzona e Valli ( Site 0201), Bellinzona, Canton Ticino, Switzerland · RECRUITING
• China Medical University Hospital ( Site 0223), Taichung, Taiwan · RECRUITING
• National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224), Tainan, Taiwan · RECRUITING
• National Taiwan University Hospital-Oncology ( Site 0225), Taipei, Taiwan · RECRUITING
• Taipei Veterans General Hospital ( Site 0221), Taipei, Taiwan · RECRUITING
• Chang Gung Medical Foundation-Linkou Branch ( Site 0222), Taoyuan, Taiwan · RECRUITING
• Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241), Ankara, Turkey (Türkiye) · COMPLETED
• Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242), Ankara, Turkey (Türkiye) · COMPLETED
• Barts Health NHS Trust ( Site 0263), London, England, United Kingdom · RECRUITING
• Royal Free Hospital ( Site 0262), London, England, United Kingdom · RECRUITING
• University Hospital Coventry & Warwickshire ( Site 0266), Coventry, United Kingdom · RECRUITING