Estimated Study Completion Date: May 2018 Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
They have also tightened up on the exclusion criteria
EXCLUSION CRITERIA ADDITIONAL CONDITIONS
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) < 21 days prior to the first dose of study drug. - Mean QT interval corrected for heart rate (QTc) >/= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction - Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroid pre-medication for CT scan contrast or study drug, is allowable, regardless of dose. - Any prior Grade >/= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1 - Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. - Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) - History of primary immunodeficiency - History of allogeneic organ transplant - History of hypersensitivity to durvalumab or any excipient - History of hypersensitivity to TPIV200 - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent - Known history of previous clinical diagnosis of tuberculosis - Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab - Subjects who are pregnant, breast-feeding or of reproductive potential who are not employing an effective method of birth control - Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results - Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results - Subjects with uncontrolled seizures - Known hypersensitivity reaction to the GM-CSF adjuvant - Patients who have developed any evidence of clinical or radiologic pneumonitis, COP/BOOP, or other lung injury, during treatment with prior FRα-targeting therapy, such as mirvetuximab soravtansine (IMGN853), or with any prior cancer immunotherapy.
