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

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