Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Locally Advanced Pancreatic Cancer

Official Title

A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer

Summary:

This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of locally advanced, unresectable pancreatic cancer subjects.

Trial Description

Primary Outcome:

• Overall Survival (OS)
• Proportion of all randomized subjects in whom R0 or R1 resection is achieved

Secondary Outcome:

• Event-free survival (EFS)
• Change in patient reported outcomes as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 Version 3.0).
• Patient-Reported Outcomes National Cancer Institute Common Terminology Criteria for Adverse Events (PRO CTCAE) Severity and Interference Items (decreased appetite, nausea, vomiting, diarrhea, abdominal pain and fatigue)
• Progression-free survival (PFS)

Subjects will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with either G/NP or FOLFIRINOX, placebo with G/NP or FOLFIRINOX. Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumour tissue will be collected during resection to determine surgical outcome and for biomarker analysis. Tumour response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines. All subjects randomized will have a safety follow-up visit approximately 28 days after the last dose of study treatment and a final safety follow-up phone call at approximately 60 days after the last dose. Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for possible R0 or R1 resection. Surgery will occur at least 4 weeks after the last dose (allowing for a wash-out period from treatment) and only after receipt of the recommendation from the central review board with regards to surgical eligibility. Surgery will occur no longer than 8 weeks after the last dose. Subjects who undergo surgery will be evaluated for surgical complications for at least an additional 90 days following discharge from surgery. Subjects who are ineligible for surgical exploration (i.e. subjects who did not complete 6 cycles of treatment or do not meet any of the protocol defined criteria or had a contraindication to surgery) will continue in the Follow-up period and receive treatment as per standard of care (SOC) for each institution. All subjects will be followed for disease progression (if not previously detected) or recurrence following resection (local progression or metastatic disease). Subjects will also be followed for any additional anti-cancer therapy received for their pancreatic cancer. All subjects will be followed for survival (until death) or until the last subject to complete treatment reaches 18 months post-treatment.

View this trial on ClinicalTrials.gov