A Platform Study of Combination Immunotherapy for the Neoadjuvant and Adjuvant Treatment of Patients With Surgically Resectable Adenocarcinoma of the Pancreas

Trial ID: NCT02451982

Interventional - Phase 2 - Active, not recruiting

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

Conditions

• Pancreatic Cancer

Interventions

• Cyclophosphamide
• GVAX pancreatic cancer
• Nivolumab
• Urelumab
• BMS-986253

Eligibility

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, National Cancer Institute (NCI), Bristol-Myers Squibb

Source: ClinicalTrials.gov

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