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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: Ezabenlimab; Drug: VSV-GP154; Drug: ATP150; Drug: ATP152; Drug: ATP162

Detailed Description

This is an open-label, phase 1b study to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of a heterologous prime-boost vaccine (protein and viral vector) regimen without/with the PD-1 inhibitor Ezabenlimab.

COMPLETED - Part A (metastatic and locally advanced PDAC patients) Cohort A: ATP150/ATP152 and VSV-GP154 treatment

ONGOING - Part B (locally advanced and resected PDAC patients) Cohort B: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment Cohort B1, B2, B3, B4: dose escalation

NOT STARTED YET - Part C (resected PDAC patients) Cohort C: ATP162, and VSV-GP154 treatment in combination with Ezabenlimab. (treatment versus observational arm)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Saint-Cloud, France, 92210
    • Institut Curie Saint-Cloud
  • Villejuif, France, 94800
    • Institut Gustave Roussy
• Germany
  • Hamburg, Germany, 22763
    • Asklepios Kliniken Hamburg GmbH
  • Heidelberg, Germany, 69120
    • Universitatsklinikum Heidelberg
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28050
    • Clara Campal Comprehesive Cancer Center
• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern
  • Geneva, Switzerland, CH-1205
    • Hopitaux Universitaires de Geneve (HUG)
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois (CHUV)
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Santa Monica, California, United States, 90404
      • University of California Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • New York
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • START South Texas Accelerated Research Therapeutics, LLC
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key inclusion criteria

• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
• ECOG performance status of 0 or 1.
• Patients with advanced or metastatic disease who completed at least 16 weeks of standard of care systemic chem-/chemoradiotherapy and achieved a partial response or stable disease.
• Patients who underwent confirmed R0 or R1 resection and completed at least 3 months of combined peri-adjuvant multiagent chemotherapy.
• No evidence of disease progression or recurrence.
• Start of study treatment within 12 weeks from the last curative treatment (resected PDAC).
• Patient must have completed 8-12 cycles of FOLFIRINOX or mFOLFIRINOX either as adjuvant, neoadjuvant, or perioperative (Part C)
• Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
• Archival tumor tissue availability for central KRAS analysis and research.

Key exclusion criteria

• Not yet recovered from surgery (resected PDAC).
• Gastro-intestinal bowel obstruction.
• Other malignancy within the last 3 years.
• Prior chemotherapy or targeted small molecule therapy within 14 (locally advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
• Prior radiotherapy within 14 days (advanced/metastatic PDAC). No prior radiotherapy. in resected PDAC
• Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
• Diagnosis of immunodeficiency, and/or history of allogeneic organ transplant
• Chronic systemic treatment with steroids or other immunosuppressive medications.
• Active autoimmune disease requiring systemic treatment within the last 2 years.
• Chronic or concurrent active infectious disease requiring systemic antibodies, antifungal, or antiviral treatment
• Major (according to the Investigator's judgment) surgery within 12 weeks from initiation of study treatment
• Use of Tamoxifen within 1 month prior to start of study treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort B	Drug: Ezabenlimab; Ezabenlimab; Drug: VSV-GP154; VSV-GP154; Drug: ATP150; ATP150; Drug: ATP152; ATP152
Experimental: Cohort A	Drug: VSV-GP154; VSV-GP154; Drug: ATP150; ATP150; Drug: ATP152; ATP152
Experimental: Cohort C Treatment	Drug: Ezabenlimab; Ezabenlimab; Drug: VSV-GP154; VSV-GP154; Drug: ATP162; ATP162
No Intervention: Cohort C Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of dose-limiting toxicity (DLT)	Part A and B	Over at least 35 days
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.	Part C	Through study completion, an average of 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with clearance and normalization of tumor biomarkers	Part B and C	Up to 12 months
Occurrence of dose-limiting toxicity (DLT) during the on-treatment period	Part B and C	Throughout the study, up to 12 months.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Shubham Pant, MD, M.D. Anderson Cancer Center; Principal Investigator: Paul Oberstein, MD, NYU Langone Health

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Estimated): June 27, 2027
• Study Completion (Estimated): June 27, 2027

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PDAC; LAPC; Locally advanced pancreatic ductal adenocarcinoma; Metastatic PDAC; Adjuvant setting; KISIMA-02; ATP150; ATP152; Ezabenlimab; VSV-GP154; Resected pancreatic ductal adenocarcinoma; Metastatic pancreatic ductal adenocarcinoma; Resected PDAC; ATP162
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Anophthalmia with pulmonary hypoplasia
• Other Study ID Numbers: 1515-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No