Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Phase 1b Study of Pembrolizumab (KEYTRUDA®) in Combination With REOLYSIN® (Pelareorep) and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma
The purpose of this Phase 1b study is to investigate whether intravenous administration of REOLYSIN® in combination with chemotherapy and pembrolizumab is effective and safe in the treatment of pancreatic adenocarcinoma.
Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) is a naturally occurring, ubiquitous,
non-enveloped human reovirus. It's primary mode of activity is to infect and selectively
target tumors with activating Ras pathway mutations. Up to 70% of pancreatic cancers have
activating Ras pathway mutations and/ or over-expressions.
This is an open label, Phase 1b study of REOLYSIN® and chemotherapy in combination with
pembrolizumab in patients with advanced (unresectable or metastatic) histologically confirmed
pancreatic adenocarcinoma that progressed after (or did not tolerate) first-line therapy. It
is thought that Reovirus when combined with chemotherapy would lead to increased viral
replication and oncolysis preferentially in RAS activated tumors, with resulting immunogenic
response than can be further enhanced by checkpoint inhibition using pembrolizumab. The study
is designed to characterize the efficacy and safety of REOLYSIN® given intravenously in
combination with one of the three chemotherapy backbone regimens, Gemcitabine, Irinotecan or
Leucovorin/ 5-fluorouracil (5-FU), and pembrolizumab, the treatment cycle of which will be
repeated every 3 weeks. It will follow a 3+3 design with no dose escalations. 3 patients will
be initially enrolled. If no dose limiting toxicities (DLT) are observed, the cohort will be
expanded. Provided patients do not develop intolerable toxicity (that does not respond to
either supportive care or dose reduction) or clinically meaningful disease progression,
treatment with additional cycles may be continued so long as patients experience clinical
benefit in the judgement of the Investigator.
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