Spots Global Cancer Trial Database for Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.
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Trial Identification
Brief Title: Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.
Official Title: Phase II Study of PolyPEPI1018 Vaccine in Combination With Atezolizumab in Participants With Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.
Study ID: NCT05243862
Conditions
Study Description
Brief Summary: This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
Detailed Description: This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens. Both agents will be administered on an every-3-week schedule until documented progression. A Simon's 2-stage design will be used for the initial assessment of efficacy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
Mayo Clinic, Jacksonville, Florida, United States
Mayo Clinic, Rochester, Minnesota, United States
Contact Details
Name: Joleen Hubbard, MD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Hagop Youssoufian, MD
Affiliation: Treos Bio Ltd.
Role: STUDY_DIRECTOR
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