En klinisk studie av MK-2870 alene eller med kjemoterapi for å behandle gastrointestinale kreft (MK-9999-02A)
En fase 1/2-studie for å evaluere sikkerheten og effekten av MK-2870 monoterapi eller i kombinasjon med andre antikreftmidler i gastrointestinale kreftformer
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
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Aktiv, ikke rekrutterende
- Westmead Hospital ( Site 0003)
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Queensland
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Brisbane, Queensland, Australia, 4029
- Aktiv, ikke rekrutterende
- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
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Victoria
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East Melbourne, Victoria, Australia, 3002
- Aktiv, ikke rekrutterende
- Epworth Freemasons ( Site 0005)
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Frankston, Victoria, Australia, 3199
- Aktiv, ikke rekrutterende
- Frankston Hospital-Oncology and Haematology ( Site 0004)
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Aktiv, ikke rekrutterende
- One Clinical Research ( Site 0002)
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Rekruttering
- The Ottawa Hospital Cancer Centre ( Site 0027)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 613-737-7700 x70185
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Quebec
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Montreal, Quebec, Canada, H2X 0A9
- Rekruttering
- Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 5148908000
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Montreal, Quebec, Canada, H4A 3J1
- Aktiv, ikke rekrutterende
- McGill University Health Centre ( Site 0023)
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Araucania
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Temuco, Araucania, Chile, 4800827
- Rekruttering
- James Lind Centro de Investigacion del Cancer ( Site 0048)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56452982404
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Region M. de Santiago
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Providencia, Region M. de Santiago, Chile, 7500921
- Aktiv, ikke rekrutterende
- FALP-UIDO ( Site 0041)
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Santiago, Region M. de Santiago, Chile, 7620002
- Rekruttering
- Clínica UC San Carlos de Apoquindo ( Site 0043)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56227548924
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Santiago, Region M. de Santiago, Chile, 8420383
- Aktiv, ikke rekrutterende
- Bradfordhill-Clinical Area ( Site 0047)
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California
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Los Angeles, California, Forente stater, 90095
- Rekruttering
- UCLA ( Site 0317)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 310-633-8400
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Anschutz Medical Campus ( Site 0299)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 303-724-8644
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Anschutz Medical Campus ( Site 0325)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 720-848-0300
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Anschutz Medical Campus ( Site 0326)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 720-848-0300
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20016
- Aktiv, ikke rekrutterende
- Sibley Memorial Hospital ( Site 0310)
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Florida
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Gainesville, Florida, Forente stater, 32610
- Rekruttering
- University of Florida College of Medicine ( Site 0281)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 352-265-5121
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Miami Beach, Florida, Forente stater, 33140
- Fullført
- Mount Sinai Cancer Center ( Site 0287)
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Georgia
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Marietta, Georgia, Forente stater, 30060
- Fullført
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
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New York
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Mineola, New York, Forente stater, 11501
- Rekruttering
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 646-599-4083
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New York, New York, Forente stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 212-731-6000
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Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- University of Texas MD Anderson Cancer Center ( Site 0316)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 713-792-2828
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Virginia
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Roanoke, Virginia, Forente stater, 24014
- Rekruttering
- Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 540-491-2240
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- Rekruttering
- University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 800-622-8922
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 390458128116
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Lombardy
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Milan, Lombardy, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 390223903807
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Milan, Lombardy, Italia, 20162
- Rekruttering
- ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 390264442291
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East ( Site 0121)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-4-7133-1111
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Rekruttering
- Kanagawa Cancer Center ( Site 0122)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-45-520-2222
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Aktiv, ikke rekrutterende
- Beijing Cancer hospital-Digestive Oncology ( Site 0061)
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Fujian
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Fuzhou, Fujian, Kina, 350025
- Rekruttering
- The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0591-22859663
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Hubei
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Wuhan, Hubei, Kina, 430024
- Aktiv, ikke rekrutterende
- Wuhan Union Hospital Cancer Center. ( Site 0064)
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Hunan
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Changsha, Hunan, Kina, 410013
- Aktiv, ikke rekrutterende
- Hunan Cancer Hospital-intervention department ( Site 0066)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200127
- Aktiv, ikke rekrutterende
- Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University ( Site 0068)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 028-85423203
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Barcelona, Spania, 08035
- Aktiv, ikke rekrutterende
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spania, 28009
- Rekruttering
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 914269070
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Principality of Asturias
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Oviedo, Principality of Asturias, Spania, 33011
- Aktiv, ikke rekrutterende
- Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
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Coventry, Storbritannia, CV2 2DX
- Rekruttering
- University Hospital Coventry & Warwickshire ( Site 0266)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02476967485
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England
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London, England, Storbritannia, E1 1RD
- Rekruttering
- Barts Health NHS Trust ( Site 0263)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 07918804584
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London, England, Storbritannia, NW3 2QG
- Rekruttering
- Royal Free Hospital ( Site 0262)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02077940500 ext38682
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Canton Ticino
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Bellinzona, Canton Ticino, Sveits, 6500
- Rekruttering
- Ospedale Regionale Bellinzona e Valli ( Site 0201)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41918119039
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Canton of Geneva
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Geneva, Canton of Geneva, Sveits, 1211
- Rekruttering
- Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41223729862
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Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital ( Site 0161)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 82-2-2072-0701
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center ( Site 0163)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82 2 3010 3945
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center ( Site 0162)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82234103549
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Seoul, Sør -Korea, 03722
- Aktiv, ikke rekrutterende
- Severance Hospital, Yonsei University Health System ( Site 0164)
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Taichung, Taiwan, 404332
- Aktiv, ikke rekrutterende
- China Medical University Hospital ( Site 0223)
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Tainan, Taiwan, 704
- Aktiv, ikke rekrutterende
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
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Taipei, Taiwan, 10002
- Aktiv, ikke rekrutterende
- National Taiwan University Hospital-Oncology ( Site 0225)
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Taipei, Taiwan, 112
- Aktiv, ikke rekrutterende
- Taipei Veterans General Hospital ( Site 0221)
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Taoyuan, Taiwan, 33305
- Aktiv, ikke rekrutterende
- Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
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Ankara, Tyrkia (Türkiye), 06800
- Fullført
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
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Ankara, Tyrkia (Türkiye), 06230
- Fullført
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
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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
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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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Given by IV infusion.
Andre navn:
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks. LV or levoleucovorin is administered by IV infusion every 2 weeks. 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. 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. |
|
Eksperimentell: 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. |
Given by IV infusion.
Andre navn:
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. 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. |
|
Eksperimentell: 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. |
Given by IV infusion.
Andre navn:
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. 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. Given by IV infusion.
Andre navn:
Given by IV infusion.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Tidsramme: Up to approximately 4 weeks
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A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported. |
Up to approximately 4 weeks
|
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Number of Participants Who Experience One or More Adverse Events (AEs)
Tidsramme: Up to approximately 63 months
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An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported. |
Up to approximately 63 months
|
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Number of Participants who Discontinue Study Treatment due to an AE
Tidsramme: Up to approximately 63 months
|
An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported. |
Up to approximately 63 months
|
|
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Tidsramme: Up to approximately 63 months
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ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. |
Up to approximately 63 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Tidsramme: Up to approximately 63 months
|
For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
Up to approximately 63 months
|
|
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Tidsramme: Up to approximately 63 months
|
PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. |
Up to approximately 63 months
|
|
Overall Survival (OS)
Tidsramme: Up to approximately 63 months
|
OS is the length of time from when the participant starts treatment until death from any cause |
Up to approximately 63 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Galleveissykdommer
- Kolonsykdommer
- Neoplasmer i galleveiene
- Kolorektale neoplasmer
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Enzymer og koenzymer
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Pyrimidiner
- Formyltetrahydrofolater
- Tetrahydrofolater
- Folsyre
- Pteriner
- Pteridiner
- Uracil
- Pyrimidinoner
- Koenzymer
- Platinumforbindelser
- Fluorouracil
- Leucovorin
- Levoleucovorin
- Cisplatin
- pembrolizumab
Andre studie-ID-numre
- 9999-02A
- MK-9999-02A (Annen identifikator: MSD)
- U1111-1298-8273 (Registeridentifikator: UTN)
- jRCT2031240178 (Registeridentifikator: jRCT)
- 2023-508703-21-00 (Registeridentifikator: EU CT)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
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