Testing immunotherapy for resectable pancreatic cancer
A Platform Study of Combination Immunotherapy for the Neoadjuvant and Adjuvant Treatment of Patients With Surgically Resectable Adenocarcinoma of the Pancreas
This study is testing different combinations of immunotherapy and chemotherapy before and after surgery to see if they can help people with resectable pancreatic cancer fight the disease better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy, cyclophosphamide |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT02451982 on ClinicalTrials.gov |
What this trial studies
This platform trial evaluates various combinations of immunotherapy given before and after surgery in patients with surgically resectable pancreatic ductal adenocarcinoma. The study focuses on using an immune system activating vaccine called GVAX alongside chemotherapy and other immune-modulating agents to enhance the immune response against pancreatic cancer. Researchers aim to understand how immune cells infiltrate tumors and how to optimize their function to combat cancer effectively. The trial will also investigate the effects of these treatments on the immune system's ability to fight cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with newly diagnosed or suspected resectable adenocarcinoma of the pancreas and an ECOG performance status of 0 to 1.
Not a fit: Patients who have previously received anti-cancer treatment or have certain autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with pancreatic cancer.
How similar studies have performed: Other studies have shown promise with immunotherapy approaches in pancreatic cancer, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed or clinically-suspected adenocarcinoma of the head, neck, or uncinate process of the pancreas * Tumor must be surgically resectable * ECOG Performance Status of 0 to 1 * Adequate organ function as defined by study-specified laboratory tests * Must agree to use acceptable form of birth control Exclusion Criteria: * Received any type of anti-cancer treatment or immunotherapy for pancreas cancer * History of autoimmune disease (Graves or Hashimoto's disease, vitiligo, and type I diabetes are allowed) * Systemically steroid use within 14 days * Evidence of active infection * Pregnant or lactating * Diagnosed with another cancer or myeloproliferative disorder (some exceptions) * History of severe hypersensitivity reaction to any monoclonal antibody or known component of the study drugs * Known history of infection with HIV, hepatitis B, or hepatitis C * Oxygen saturation of \<92% on room air by pulse oximetry * On home oxygen
Where this trial is running
Baltimore, Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ana De Jesus-Acosta, MD — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
- Study coordinator: Colleen Apostol, RN
- Email: GIClinicalTrials@jhmi.edu
- Phone: 410-614-3644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.