A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic C… (NCT05846516) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer
United States, Germany, Spain58 participantsStarted 2023-05-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial combining the KISIMA-02 vaccine with a checkpoint inhibitor called ezabenlimab, what does that mean for what we actually know so far about how safe or effective this combination is for pancreatic ductal adenocarcinoma?
2The trial is actively measuring dose-limiting toxicity — what kinds of side effects are being watched for, and how might they affect my daily life or my ability to continue other treatments if needed?
3The study is no longer recruiting new participants — does that mean I've missed my window entirely, or are there other similar vaccine-based or immunotherapy trials I might still be eligible for?
4This trial tracks disease-free survival, meaning how long before any relapse or death — given that I have pancreatic ductal adenocarcinoma, how does that outcome measure compare to what I might expect from standard treatment options right now?
5Would you recommend exploring standard chemotherapy or other established treatments first before considering an experimental immunotherapy trial like this one, and what factors would influence that decision for my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of dose-limiting toxicity (DLT)
Timeframe: Over at least 35 days
2
Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.
Timeframe: Through study completion, an average of 24 months.