Health Trials

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sacituzumab tirumotecan
  • Fluorouracil (5-FU)
  • Leucovorin (LV) or levoleucovorin
  • Rescue medication
  • Supportive care measures
  • Cisplatin
  • Pembrolizumab

Treatment groups

220 Participants
are divided into 3 treatment groups

Locations

55
Australia
Westmead Hospital ( Site 0003)2145, WestmeadNew South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)4029, BrisbaneQueensland, Australia
Epworth Freemasons ( Site 0005)3002, East MelbourneVictoria, Australia
Frankston Hospital-Oncology and Haematology ( Site 0004)3199, FrankstonVictoria, Australia

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov