RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Quick Facts

Study Start:2023-05-25
Study Completion:2029-05-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05846516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Boehringer Ingelheim
CONTACT
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
University of California Los Angeles
Santa Monica, California, 90404
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
University of Florida
Gainesville, Florida, 32610
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York, 10016
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
START South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-25
Study Completion Date2029-05-15

Study Record Updates

Study Start Date2023-05-25
Study Completion Date2029-05-15

Terms related to this study

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma