Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Pancreatic Ductal Adenocarcinoma, sponsored by Boehringer Ingelheim.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Part A and B
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-05-11 |
| Est. Completion | 2027-06-27 |
| Phase | Phase 1 |
What the registry record for NCT05846516 still lists
NCT05846516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (90% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Pancreatic Ductal Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05846516's enrollment target sits among peer trials
58 54th of 84 higher than 31 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
-
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
RECRUITING · Phase 1
-
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03587844 · 58 participants · Phase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
- NCT03630991 · 58 participants · Phase 1
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
- NCT03949855 · 58 participants · Phase 2
Belimumab With Rituximab for Primary Membranous Nephropathy
- NCT04069273 · 58 participants · Phase 2
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI