Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Bristol-Myers Squibb; National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Nivolumab; Pancrelipase; Vaccines

Criteria

Inclusion Criteria:

• Newly diagnosed 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