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NCT05846516 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Pancreatic Ductal Adenocarcinoma, sponsored by Boehringer Ingelheim.

Active
Registry status
Phase 1
Development phase
58
Enrollment target
20
Study locations

NCT05846516 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 58 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT05846516, a Phase 1 study of Pancreatic Ductal Adenocarcinoma, is active but no longer recruiting, sponsored by Boehringer Ingelheim.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
58 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Pancreatic Ductal Adenocarcinoma

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

515 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, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (90% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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.

NCT05846516 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Florida.

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.

What interventions are being tested in trial NCT05846516?

The interventions under investigation include: Ezabenlimab (DRUG), VSV-GP154 (DRUG), ATP150 (DRUG), ATP152 (DRUG), ATP162 (DRUG).

Who is sponsoring clinical trial NCT05846516?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.