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

NCT05846516 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 1515-0001
• Study Type: interventional
• Target: 58
• Locations: 5 countries
• Sites: 24

Brief 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

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Proportion of patients with clearance and normalization of tumor biomarkers

  Up to 12 months

• Occurrence of dose-limiting toxicity (DLT) during the on-treatment period

  Throughout the study, up to 12 months.

Study Arms (4)

Cohort A

EXPERIMENTAL

Drug: VSV-GP154; Drug: ATP150; Drug: ATP152

Cohort B

EXPERIMENTAL

Drug: VSV-GP154; Drug: ATP150; Drug: ATP152; Drug: Ezabenlimab

Cohort C Treatment

EXPERIMENTAL

Drug: VSV-GP154; Drug: Ezabenlimab; Drug: ATP162

Cohort C Observational

NO INTERVENTION

Interventions

VSV-GP154 DRUG

VSV-GP154

Cohort A; Cohort B; Cohort C Treatment

ATP150 DRUG

ATP150

Cohort A; Cohort B

ATP152 DRUG

ATP152

Cohort A; Cohort B

Ezabenlimab DRUG

Ezabenlimab

Cohort B; Cohort C Treatment

ATP162 DRUG

ATP162

Cohort C Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (24)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California Los Angeles

Santa Monica, California, 90404, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

New York, New York, 10016, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

START South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Institut Curie Saint-Cloud

Saint-Cloud, 92210, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Asklepios Kliniken Hamburg GmbH

Hamburg, 22763, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Clara Campal Comprehesive Cancer Center

Madrid, 28050, Spain

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Geneve (HUG)

Geneva, CH-1205, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 6, 2023
• Study Start: May 11, 2023
• Primary Completion (Estimated): June 27, 2027
• Study Completion (Estimated): June 27, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); CH (3); ES (5); US (12); DE (2)