What side effects are associated with this type of intervention?

Common side effects of immunotherapy treatments for pancreatic cancer, such as those involving therapeutic protein vaccines, viral vectors, and immune checkpoint inhibitors, include skin reactions (rash, pruritus), endocrine events (thyroid dysfunction), gastrointestinal issues (diarrhea, nausea), and fatigue. Severe adverse events can include pneumonitis, hepatitis, and colitis. Immune checkpoint inhibitors like nivolumab and ipilimumab may also cause immune-related adverse events that require management with immunosuppressive agents.

What prior FDA approvals exist?

The FDA has approved several immunotherapy treatments for various cancers, but specific approvals for pancreatic cancer involving a combination of a therapeutic protein vaccine, viral vector, and immune checkpoint inhibitor are limited. Immune checkpoint inhibitors like pembrolizumab (Keytruda) and nivolumab (Opdivo) have been approved for other cancers and are being explored in pancreatic cancer. However, the combination approach of a therapeutic protein vaccine, viral vector, and immune checkpoint inhibitor as seen in the KISIMA-02 trial represents a novel and investigational strategy in the treatment of pancreatic cancer.

What other types of research exist?

Promising novel alternatives to KISIMA-02 for pancreatic cancer patients include: 1) Pembrolizumab (Keytruda), an anti-PD-1 therapy, which has shown efficacy in various cancers and is being explored in pancreatic cancer. 2) Nivolumab (Opdivo) combined with Ipilimumab (Yervoy), both immune checkpoint inhibitors, which have shown promise in other cancers and are under investigation for pancreatic cancer. 3) CAR-T cell therapy, which involves modifying a patient's T cells to target cancer cells, is an emerging area of research in pancreatic cancer. 4) Oncolytic virus therapy, which uses genetically modified viruses to kill cancer cells and stimulate an immune response, is also being explored. Patients should discuss these options with their oncologist to determine the best course of action based on their specific condition.

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Cancer Vaccine

Immunotherapy for Pancreatic Cancer

Phase 1

Recruiting

Led By Paul Oberstein, MD

Research Sponsored by Amal Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study, on average 2.4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for pancreatic cancer using a special vaccine, a virus for delivery, and an immune-boosting drug. It aims to help the immune system better fight cancer in patients whose disease has spread, is locally advanced, or has been surgically removed. Vaccine therapy is being tested for many forms of cancer, including pancreatic cancer, with early trials showing safety and some increased survival.

Who is the study for?

This trial is for pancreatic cancer patients with a specific mutation (KRAS G12D/G12V). They must have had surgery and chemotherapy, be in good physical condition, and not show signs of cancer returning. Those who've recently used certain drugs or treatments, have immune deficiencies or active autoimmune diseases, other recent cancers, or haven't recovered from surgery are excluded.

What is being tested?

The KISIMA-02 study tests an immunotherapy treatment on pancreatic cancer. It includes a protein vaccine (ATP150/152), a viral vector (VSV-GP154), and an immune checkpoint inhibitor (Ezabenlimab). The first part checks safety; the second compares treated patients to those only observed.

What are the potential side effects?

Potential side effects may include typical reactions to vaccines like soreness at injection site, fatigue, flu-like symptoms; for Ezabenlimab: inflammation in organs similar to autoimmune responses, infusion-related reactions and increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study, on average 2.4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study, on average 2.4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, on average 2.4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free survival (DFS), defined as the time from randomization until confirmed relapse or death from any cause, whichever occurs earlier.

Secondary study objectives

Occurrence of dose-limiting toxicity (DLT)

Proportion of patients achieving ctDNA clearance

Proportion of patients experiencing ctDNA non-progression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Cohort C TreatmentExperimental Treatment4 Interventions

Group II: Cohort BExperimental Treatment4 Interventions

Group III: Cohort AExperimental Treatment3 Interventions

Group IV: Cohort C ObservationalActive Control1 Intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The KISIMA-02 trial for pancreatic cancer involves a combination of immunotherapy treatments designed to stimulate the immune system to target cancer cells. The therapeutic protein vaccine (ATP150 or ATP152) aims to elicit a specific immune response against tumor-associated antigens. The viral vector (VSV-GP154) is used to deliver genetic material into cells, enhancing the immune system's ability to recognize and attack cancer cells. The immune checkpoint inhibitor (Ezabenlimab) blocks proteins that inhibit immune responses, thereby allowing T-cells to effectively target and destroy cancer cells. These mechanisms are crucial for pancreatic cancer patients as they offer a targeted approach to boost the body's natural defenses against a notoriously aggressive and difficult-to-treat cancer.