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

NCT ID: NCT05846516

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2029-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A

Group Type EXPERIMENTAL

VSV-GP154

Intervention Type DRUG

VSV-GP154

ATP150

Intervention Type DRUG

ATP150

ATP152

Intervention Type DRUG

ATP152

Cohort B

Group Type EXPERIMENTAL

VSV-GP154

Intervention Type DRUG

VSV-GP154

ATP150

Intervention Type DRUG

ATP150

ATP152

Intervention Type DRUG

ATP152

Ezabenlimab

Intervention Type DRUG

Ezabenlimab

Cohort C Treatment

Group Type EXPERIMENTAL

VSV-GP154

Intervention Type DRUG

VSV-GP154

Ezabenlimab

Intervention Type DRUG

Ezabenlimab

ATP162

Intervention Type DRUG

ATP162

Cohort C Observational

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VSV-GP154

VSV-GP154

Intervention Type DRUG

ATP150

ATP150

Intervention Type DRUG

ATP152

ATP152

Intervention Type DRUG

Ezabenlimab

Ezabenlimab

Intervention Type DRUG

ATP162

ATP162

Intervention Type DRUG

Eligibility Criteria

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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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

University of California Los Angeles

Santa Monica, California, United States

Site Status RECRUITING

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

New York, New York, United States

Site Status RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

START South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

Site Status RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Site Status RECRUITING

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Asklepios Kliniken Hamburg GmbH

Hamburg, , Germany

Site Status RECRUITING

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Clara Campal Comprehesive Cancer Center

Madrid, , Spain

Site Status RECRUITING

University Hospital Bern

Bern, , Switzerland

Site Status RECRUITING

Hopitaux Universitaires de Geneve (HUG)

Geneva, , Switzerland

Site Status RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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United States Germany Spain Switzerland

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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1515-0001

Identifier Type: -

Identifier Source: org_study_id