RECRUITING

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

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

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Official Title

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

Quick Facts

Study Start:2022-10-24
Study Completion:2028-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05253651

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. * Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
  2. * Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
  3. * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
  4. * HER2+ disease as determined by a tissue based assay performed at a central laboratory.
  5. * Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
  6. * Radiographically measurable disease per RECIST v1.1 with:
  7. * At least one site of disease that is measurable and that has not been previously irradiated, or
  8. * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
  9. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  10. * CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:
  11. * No evidence of brain metastases
  12. * Previously treated brain metastases which are asymptomatic
  1. * Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.
  2. * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \>6 months prior to enrollment
  3. * Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
  4. * Previous treatment with anti-HER2 therapy
  5. * Ongoing Grade 3 or higher neuropathy
  6. * Active or untreated gastrointestinal (GI) perforation at the time of screening.

Contacts and Locations

Study Contact

Seagen Trial Information Support
CONTACT
866-333-7436
clinicaltrials@seagen.com

Principal Investigator

Medical Monitor
STUDY_DIRECTOR
Seagen Inc.

Study Locations (Sites)

Palo Verde Cancer Specialists
Glendale, Arizona, 85304
United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Pacific Cancer Medical Center
Anaheim, California, 92801-1830
United States
Los Angeles Cancer Network
Los Angeles, California, 90017
United States
Kaiser Permanente Southern California
Los Angeles, California, 90027
United States
University of Southern California
Los Angeles, California, 90033
United States
University of Southern California
Newport Beach, California, 92663
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
Rocky Mountain Cancer Centers - Aurora
Denver, Colorado, 80218
United States
Mount Sinai Medical Center / Florida
Miami Beach, Florida, 33140
United States
Woodlands Medical Specialists
Pensacola, Florida, 32503
United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, 30303
United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, 30322
United States
MidAmerica Cancer Center, LLC
Merriam, Kansas, 66204
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Norton Cancer Institute
Louisville, Kentucky, 40217
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
HealthPartners Institute
Saint Louis Park, Minnesota, 55416
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374
United States
Gabrail Cancer Center Research
Canton, Ohio, 44718
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Portland Medical Center
Portland, Oregon, 97225
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, 75246
United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030
United States
Texas Oncology - McKinney
McKinney, Texas, 75071
United States
Texas Oncology - Northeast Texas
Paris, Texas, 75460
United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Roanoke, Virginia, 24014
United States
Providence Regional Medical Center Everett
Everett, Washington, 98201
United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Seagen Inc.

  • Medical Monitor, STUDY_DIRECTOR, Seagen Inc.

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 Date2022-10-24
Study Completion Date2028-04-30

Study Record Updates

Study Start Date2022-10-24
Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

  • Colorectal Cancer
  • CRC
  • Seattle Genetics

Additional Relevant MeSH Terms

  • Colorectal Neoplasms