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ACTIVE NOT RECRUITING
NCT05846516
PHASE1

A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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

Interventions

DRUG

VSV-GP154

VSV-GP154

DRUG

ATP150

ATP150

DRUG

ATP152

ATP152

DRUG

Ezabenlimab

Ezabenlimab

DRUG

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