A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
• Age ≥18 years.
• Have histologically or cytologically - proven adenosquamous carcinoma of the pancreas or ampulla.
• Has unresectable or metastatic measurable disease.
• Has received (or been intolerant to or ineligible for) at least 1 prior line of cytotoxic chemotherapy and received no more than 2 prior systemic treatments.
• Presence of at least one lesion with measurable disease.
• Accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• If HIV-positive, then all of the following criteria must also be met: cluster of differentiation (CD) 4+ count ≥ 350/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
• Life expectancy of greater than 3 months.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
• Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
• Men must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.