Spots Global Cancer Trial Database for Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
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Trial Identification
Brief Title: Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
Official Title: A Phase 1/2, Safety Lead-in and Dose Expansion, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination With Nivolumab and Ipilimumab in Previously Treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Study ID: NCT05921760
Conditions
Study Description
Brief Summary: This is a Phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma. The study includes two phases: the safety lead-in phase to determine the recommended combination dose (RCD) of ivosidenib in combination with immunotherapy and the dose expansion phase to assess the efficacy of ivosidenib in combination with immunotherapy. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Scottsdale, Arizona, United States
The University of Arizona Cancer Center (Uacc), Tucson, Arizona, United States
UCSF - Medical Center at Mission Bay, San Francisco, California, United States
Ucsf Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Mayo Clinic - Jacksonville, Fl, Jacksonville, Florida, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
The University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic - Rochester, Mn, Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The University of Texas Md Anderson Cancer Center, Houston, Texas, United States
Clatterbridge Hospital, Bebington, , United Kingdom
UCLH, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Contact Details
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