Pancreatic Cancer Resectable Clinical Trial
Official title:
Randomized Phase II Trial of Pre-Operative Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine With or Without Avelumab (PGHA vs. PGH)
This is a randomized phase II trial that will examine the ability of Avelumab to improve the clinical activity of a pre-operative regimen of gemcitabine, nab-paclitaxel and hydroxychloroquine in subjects with potentially resectable adenocarcinoma of the pancreas.
This is a phase II, non-blinded, adaptively randomized trial. Patients with PDA are evaluated
prior to protocol entry by standard of care testing, including EUS, contrast-enhanced helical
abdominal CT scan, or MRI. Patients meeting NCCN criteria for potentially resectable
(borderline or resectable) tumors will be eligible. Subjects are randomized to receive either
2 cycles of PGH ─ gemcitabine and nab-paclitaxel (1000 mg/m2 & 125 mg/m2, respectively: days
1, 8, and 15) plus oral HCQ (1200 mg PO daily) ─ or PGH plus Avelumab (PGHA; days 1 and 15 of
each 28-day cycle), by means of response-adaptive randomization based on Grade IIB or greater
histologic response.
Surgical exploration and pancreatectomy is performed if technically feasible and all
toxicities have resolved. HCQ is taken until the evening before surgery. Avelumab is
administered every two weeks until up to one week prior to the date of surgery. The Study
Coordinator informs subjects of the date of operation. Following successful surgical removal
of tumors, patients are then be free to pursue standard of care adjuvant therapy options, at
the discretion of their treating physician.
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