Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
Single-Arm, Phase II Proof of Concept Study of IDO-1 Inhibitor Epacadostat in Combination With Pembrolizumab in Advanced Pancreatic Cancer With Chromosomal Instability/Homologous Recombination Repair Deficiency (HRD)
This phase II trial studies how well epacadostat and pembrolizumab work in treating participants with pancreatic cancer that has spread to other places in the body. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving epacadostat and pembrolizumab may work better in treating participants with pancreatic cancer.
PRIMARY OBJECTIVES:
I. To determine the efficacy of epacadostat in combination with pembrolizumab as determined
by the best overall response rate in previously treated patients with advanced pancreatic
adenocarcinoma with homologous recombination repair deficiency (HRD) aberrations.
SECONDARY OBJECTIVES:
I. To further determine the efficacy of epacadostat in combination with pembrolizumab in
previously treated patients with advanced pancreatic adenocarcinoma with HRD aberrations.
II. To assess the safety and tolerability of epacadostat in combination with pembrolizumab in
previously treated patients with advanced pancreatic adenocarcinoma with HRD aberrations.
EXPLORATORY OBJECTIVES:
I. To identify predictive, mechanistic, and/or surrogate biomarkers of clinical efficacy of
epacadostat in combination with pembrolizumab in previously treated patients with advanced
pancreatic adenocarcinoma with HRD aberrations utilizing exploratory studies investigating
the patients tumor and immune system response including: flow cytometry of fresh peripheral
blood mononuclear cell (PBMC), PDL-1.
OUTLINE:
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and
epacadostat orally (PO) twice daily (BID) on days 1-21. Cycles repeat every 21 days in the
absence of disease progression or unaccepted toxicity.
After completion of study treatment, participants are followed up at 30 days, every 8 weeks
for 3 years, and then every 12 weeks thereafter.
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