Pancreatic Ductal Adenocarcinoma
Conditions
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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of dose-limiting toxicity (DLT) | Over at least 35 days | Part A and B |
| Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier. | Through study completion, an average of 24 months. | Part C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with clearance and normalization of tumor biomarkers | Up to 12 months | Part B and C |
| Occurrence of dose-limiting toxicity (DLT) during the on-treatment period | Throughout the study, up to 12 months. | Part B and C |
Countries
France, Germany, Spain, Switzerland, United States
Outcome results
None listed