Comparing Two Vaccine Treatments With Immunotherapy for Pancreatic Cancer Before and After Surgery
Treatment
Phase 1b/2 treatment study for newly diagnosed pancreatic cancer that can be removed with surgery and who have not yet received treatment
Clinicaltrials.gov identifier:NCT06782932
Study Contact Information:
For additional information, please contact:
Name: Colleen Apostol, RN
Phone Number: 410-614-3644
Email: [email protected]
About the Study
This study is evaluating two approaches designed to help the immune system recognize and attack pancreatic cancer:
- A KRAS-targeted vaccine, which focuses on a common mutation found in pancreatic cancer
- A whole-cell vaccine (GVAX), which trains the immune system to recognize multiple features of cancer cells
All participants will receive a combination of treatments before and after surgery, including:
- A study vaccine (one of the two options above)
- Chemotherapy (cyclophosphamide)
- Two drugs (balstilimab and AGEN2373)
These treatments are designed to work together to strengthen the immune response to cancer.
This Study is Open To:
People who are 18 years and older, who meet the following criteria:
- Have pancreatic cancer that meets the following criteria:
- Newly diagnosed
- Biopsy-proven of the pancreas
- Tumor can be removed surgically
- Have not yet received treatment for their pancreatic cancer
- Are healthy enough to participate based on lab tests and overall condition
- Willing to attend study visits, undergo required surgical resection, treatments and testing
- For women, be non-pregnant and use contraceptives for the study duration
- For men, use contraceptives for the study duration
This Study is NOT Open To:
People who:
- Have already received any pancreatic cancer treatment (such as radiation, chemotherapy, etc)
- Have received for previous cancer treatment
- Pancreatic cancer is not surgically removable
- Have an active autoimmune condition or require medications that weaken the immune system
- Have active infections such as HIV, Hepatitis B or Hepatitis C
- Have had major surgery or a live vaccine within 28 days of study treatment
- Have certain complications, such as fluid buildup (ascites/pleural effusion) or lung issues
- Are pregnant or breastfeeding
- Prior organ or stem cell transplantation
- Have a hypersensitivity to any monoclonal antibody
- Already enrolled in another therapeutic clinical study
What the Study Involves
If you join this study:
- You will be assigned to one of two treatment groups.
- You will receive study treatment before surgery to remove your cancer.
- You will continue treatment after surgery.
During the study, participants will:
- Have regular clinic visits for treatment and monitoring
- Undergo blood tests and physical exams
- Have imaging scans to monitor their cancer
- Be followed for up to 2 years after treatment
People are assigned to one of two treatment arms in this study, with 6 treatment cycles total.
Cycle 1 will be before surgery, and Cycle 2 will be after surgery, both 14 days long. Cycles 3-6 will be 28 days long each.
- Treatment Group 1:
- GVAX (vaccine): Given as an injection on day 2 of each cycle for 6 cycles total
- Balstilimab (): Given as an IV infusion on day 1 of each cycle
- Cyclophosphamide (chemotherapy): Given as an IV infusion on day 1 of each cycle
- AGEN2373 (): Given as an IV infusion on day 1 of each cycle
- Treatment Group 2:
- mKRASvax (vaccine): Given as an injection on day 1 of each cycle as well as Day 8 of cycle 1 only
- Balstilimab (): Given as an IV infusion on day 1 of each cycle
- Cyclophosphamide (chemotherapy): Given as an IV infusion on day 1 of each cycle
- AGEN2373 (): Given as an IV infusion on day 1 of each cycle
Study Contact Information:
For additional information, please contact:
Name: Colleen Apostol, RN
Phone Number: 410-614-3644
Email: [email protected]
Locations:
Maryland
City: Baltimore RECRUITING
Facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Contact Info:
[email protected]
410-614-3644
Eric Christenson, MD
Treatment
Phase 1b/2 treatment study for newly diagnosed pancreatic cancer that can be removed with surgery and who have not yet received treatment
Clinicaltrials.gov identifier:NCT06782932
Study Contact Information:
For additional information, please contact:
Name: Colleen Apostol, RN
Phone Number: 410-614-3644
Email: [email protected]