NCT03344172

Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer

Randomized Phase II Trial of Pre-Operative Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine With or Without Avelumab (PGHA vs. PGH)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Nathan Bahary, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer Resectable

Interventions

Type	Name	Description
DRUG	Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab	Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)
DRUG	Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine	Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Timeline

• Start date: 2017-12-13
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2017-11-17
• Last updated: 2020-05-14
• Results posted: 2020-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study