RECRUITING

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

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Conditions

Colorectal CancerPancreatic Ductal AdenocarcinomaBiliary Tract Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

Quick Facts

Study Start:2024-06-20
Study Completion:2029-10-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06428409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has one of the following cancers:
  2. * Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer
  3. * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
  4. * Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
  5. * Advanced and/or unresectable BTC and has not received prior therapy for the cancer
  6. * For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment
  1. * History of severe eye disease
  2. * For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
  3. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

UCLA ( Site 0317)
Los Angeles, California, 90095
United States
University of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado, 80045
United States
UCHealth Cherry Creek Medical Center ( Site 0326)
Denver, Colorado, 80206
United States
UCHealth Highlands Ranch Hospital ( Site 0325)
Highlands Ranch, Colorado, 80129
United States
Sibley Memorial Hospital ( Site 0310)
Washington, 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

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-20
Study Completion Date2029-10-16

Study Record Updates

Study Start Date2024-06-20
Study Completion Date2029-10-16

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Biliary Tract Cancer