This study has stopped recruitment. Adults with advanced pancreatic cancer participate in this study. The study tests a type of immunotherapy. It is a protein treatment (ATP150/ATP152/ATP162) combined with a virus (VSV-GP154) that may kill cancer cells and help the immune system fight cancer. The immunotherapy is combined with a study medicine called ezabenlimab. Ezabenlimab is an antibody that may also help the immune system fight cancer. The purpose is to find the highest dose of the immunotherapy that people with pancreatic cancer can tolerate when taken alone or together with ezabenlimab (Part A and B). To find out, researchers look at the number of participants with certain severe health problems. The original purpose of the subsequent Part C was to check whether the immunotherapy combined with ezabenlimab may increase survival and prevent the cancer getting worse over time. The recruitment into Part C was not continued and stopped. Participants can stay in the study as long as they tolerate the treatment or up to 1 year. During that time, they regularly visit the site. At all visits, the doctors closely check the health of the participants and note any severe health problems.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
University of Southern California
Los Angeles, California, United States
University of California Los Angeles
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
START South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
...and 11 more locations
Occurrence of dose-limiting toxicity (DLT)
Part A and B
Time frame: Over at least 35 days
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.
Part C
Time frame: Through study completion, an average of 24 months.
Occurrence of dose-limiting toxicity (DLT) during the on-treatment period
Part B and C
Time frame: Throughout the study, up to 12 months.
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