NCT03432676

Epacadostat and Pembrolizumab in Treating Participants With Advanced Pancreatic Cancer

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• ATM Gene Mutation
• Deleterious BRCA1 Gene Mutation
• Deleterious BRCA2 Gene Mutation
• Homologous Recombination Deficiency
• Pancreatic Ductal Adenocarcinoma
• Stage II Pancreatic Cancer AJCC v8
• Stage IIA Pancreatic Cancer AJCC v8
• Stage IIB Pancreatic Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Epacadostat	Given PO
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2019-07-31
• Primary completion: 2020-04-30
• Completion: 2021-04-30
• First posted: 2018-02-14
• Last updated: 2019-05-30

Regulatory

• FDA-regulated drug study