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A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer
Sponsor: Boehringer Ingelheim
Summary
This study is open to adults with advanced pancreatic cancer. The study tests a type of immunotherapy. It is a protein treatment combined with a virus 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 purpose of Part C is to check whether the immunotherapy combined with ezabenlimab may increase survival. Participants are put randomly into 2 groups. One group receives the immunotherapy combined with ezabenlimab and the other group receives standard treatment. Researchers compare the results between the groups. 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.
Official title: A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Heterologous Prime Boost Vaccination (ATP150/ATP152/ATP162, VSV-GP154) and Ezabenlimab (BI 754091) in Patients With Pancreatic Ductal Adenocarcinoma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2023-05-11
Completion Date
2027-06-27
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
VSV-GP154
VSV-GP154
ATP150
ATP150
ATP152
ATP152
Ezabenlimab
Ezabenlimab
ATP162
ATP162
Locations (24)
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
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Institut Curie Saint-Cloud
Saint-Cloud, France
Institut Gustave Roussy
Villejuif, France
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Clara Campal Comprehesive Cancer Center
Madrid, Spain
University Hospital Bern
Bern, Switzerland
Hopitaux Universitaires de Geneve (HUG)
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland