Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers
NCT05153304 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2024-06-10
Summary
The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.
Conditions
- Cancer of Gastrointestinal Tract
Interventions
- BIOLOGICAL
-
personalized vaccine
Vaccine will be constructed for each subject that express multiple candidate tumor-derived neoantigens.
- DRUG
-
3mg/kg nivolumab will be administered intravenous (IV) infusion every 3 weeks for 4 doses. After 4 doses, 480 mg nivolumab will be administered intravenous (IV) infusion every 4 weeks.
Sponsors & Collaborators
-
University of California, San Diego
lead OTHER
Principal Investigators
-
Ezra Cohen, MD · University of California, San Diego
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-30
- Primary Completion
- 2026-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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