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ACTIVE NOT RECRUITING Phase 1

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

NCT05846516 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Ezabenlimab
  • DRUG VSV-GP154
  • DRUG ATP150
  • DRUG ATP152
  • DRUG ATP162

Study Locations (20)

Other

  • Institut Curie Saint-Cloud — Saint-Cloud
  • Institut Gustave Roussy — Villejuif
  • Asklepios Kliniken Hamburg GmbH — Hamburg
  • Universitätsklinikum Heidelberg — Heidelberg
  • Hospital Universitari Vall D Hebron — Barcelona
  • Hospital Universitario Reina Sofía — Córdoba
  • Hospital General Universitario Gregorio Marañón — Madrid
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid

California

  • University of Southern California — Los Angeles
  • University of California Los Angeles — Santa Monica

Florida

  • University of Florida — Gainesville
  • Orlando Health Cancer Institute — Orlando

Texas

  • The University of Texas MD Anderson Cancer Center — Houston
  • START South Texas Accelerated Research Therapeutics, LLC — San Antonio

Colorado

  • University of Colorado Cancer Center — Aurora

Michigan

  • Karmanos Cancer Institute — Detroit

New York

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island — New York

Ohio

  • University Hospitals Cleveland Medical Center — Cleveland

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2023-05-11
Est. Completion 2027-06-27
Phase Phase 1

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05846516

The ClinicalTrials.gov registry entry for NCT05846516 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Ezabenlimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05846516 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05846516 about?

NCT05846516 is a clinical study titled "A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer". 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. Ezabenlim...

What is the current status of trial NCT05846516?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2023-05-11. Estimated completion is 2027-06-27.

What conditions does trial NCT05846516 study?

This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05846516?

The interventions under investigation include: Ezabenlimab (DRUG), VSV-GP154 (DRUG), ATP150 (DRUG), ATP152 (DRUG), ATP162 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05846516?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05846516 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial