incmga00012 in patients with previously treated unresectable or metastatic adenosquamous pancreatic or ampullary cancer

Conditions: Pancreatic Cancer Non-resectable; Pancreatic Cancer Metastatic

Summary: phase 2 study to evaluate the clinical activity of incmga00012 in patients with unresectable or metastatic adenosquamous pancreatic or ampullary cancer.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria * known history or evidence of brain metastases. * has had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study drug. * has received an investigational agent or used an investigational device within 28 days of the first dose of study drug. * expected to require any other form of systemic or localized antineoplastic therapy while on study. * has had major surgery within 28 days of dosing of investigational agent, excluding minor procedures. * has received a live vaccine within 28 days prior to the first dose of study drug. * prior treatment with immunotherapy agents (including, anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla4, anti-ox40 and lag-3 antibodies) * have used any systemic steroids within 14 days of study treatment. * hypersensitivity reaction to any monoclonal antibody. * evidence of clinical or radiographic ascites. * have clinically significant and/or malignant pleural effusion. * uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements. * history of autoimmune disease requiring systemic immunosuppression within the last 2 years. * presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. patients with a history of allogeneic hematopoeitic stem cell transplant will be excluded. * all toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to a grade 1 or baseline before administration of study drug. * infection with hepatitis a, b or c. * patient has a pulse oximetry of \<92% on room air. * patient is on supplemental home oxygen. * has an unhealed surgical wound or ulcer, or a bone fracture considered non-healing. * patient has clinically significant heart disease. * patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse. * unwilling or unable to follow the study schedule for any reason. * patient has history of non-infectious pneumonitis. * serum albumin level less than 2.8 g/dl.

Keywords: antibody anti-pd-1 human monoclonal immunoglobulin antibody immunotherapy incmga00012 (anti-pd-1 antibody) anti-pd-1 antibody (mga012) metastatic adenosquamous pancreatic cancer unresectable adenosquamous pancreatic cancer adenosquamous pancreatic cancer programmed cell death protein 1 (pd-1) programmed death-ligand 1 (pd-l1)