A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Recruiting · NCT06428409 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
CisplatinFluorouracil (5-FU)Leucovorin (LV) or levoleucovorinPembrolizumabRescue medicationSacituzumab tirumotecanSupportive care measures
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 9 US states.
- UCLA ( Site 0317) - Los Angeles, California, United States
- 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
- 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
- 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
- University of Florida College of Medicine ( Site 0281) - Gainesville, Florida, United States
- Mount Sinai Cancer Center ( Site 0287) - Miami Beach, 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
- 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
- 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
- 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
- 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
- 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
- University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293) - Madison, Wisconsin, United States
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242) - Ankara, Turkey (Türkiye)
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242) - Ankara, Turkey (Türkiye)
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181) - Barcelona, Spain
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181) - Barcelona, Spain
- University Hospital Coventry & Warwickshire ( Site 0266) - Coventry, United Kingdom
- University Hospital Coventry & Warwickshire ( Site 0266) - Coventry, United Kingdom
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103) - Roma, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103) - Roma, Italy
- 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
- 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
- China Medical University Hospital ( Site 0223) - Taichung, Taiwan
- China Medical University Hospital ( Site 0223) - Taichung, Taiwan
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224) - Tainan, 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
- 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, Taiwan
- Chang Gung Medical Foundation-Linkou Branch ( Site 0222) - Taoyuan, Taiwan
- James Lind Centro de Investigacion del Cancer ( Site 0048) - Temuco, Araucania, Chile
- James Lind Centro de Investigacion del Cancer ( Site 0048) - Temuco, Araucania, Chile
- Beijing Cancer hospital-Digestive Oncology ( Site 0061) - Beijing, Beijing Municipality, China
- Beijing Cancer hospital-Digestive Oncology ( Site 0061) - Beijing, Beijing Municipality, China
- Ospedale Regionale Bellinzona e Valli ( Site 0201) - Bellinzona, Canton Ticino, Switzerland
- Ospedale Regionale Bellinzona e Valli ( Site 0201) - Bellinzona, Canton Ticino, Switzerland
Showing 60 of 110 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →