Ensayos clínicos

Inclusion Criteria:

• Be willing and able to provide written informed consent/assent for the trial
• Be 18 years of age on day of signing informed consent.
• Have measurable disease based on RECIST 1.1.
• Have completed 4-8 cycles of FOLFIRINOX prior to randomization and > 2 weeks but < 4 weeks prior to Cycle 1 Day 1 of treatment.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Demonstrate adequate organ function as defined in Table 2.
• In subjects requiring biliary decompression, metal stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed. Subjects having plastic stent placement are not eligible
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication.  If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 
• Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.5.3).  Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion Criteria:

• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of trial treatment.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has a plastic biliary stent for decompression
• Has metastatic disease as determined by CT scan or MRI
• Has had prior surgery, chemotherapy (other than 4-8 cycles of FOLFIRINOX), targeted small molecule therapy, or radiation therapy for pancreatic cancer or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment fields. Note:  If subject received major surgery for reason other than pancreatic cancer, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has a known additional malignancy that is progressing or requires active treatment.  Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 
• Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.  Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule.  Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study.
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Has an active serious infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). In patients without a known history of Hepatitis B or C, serologies should be obtained at screening.
• Has received a live vaccine within 30 days prior to the first dose of trial treatment. 
• Subjects who are unable or unwilling to discontinue use of prohibited medications.
• Subject is unable or unwilling to participate in a study related procedure.
• Subject is a prisoner.
• Significant history of uncontrolled cardiac disease defined as uncontrolled hypertension; unstable angina; myocardial infarction within the last 4 months; or uncontrolled congestive heart failure.
• A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.