CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Epacadostat +4 moredrug
Likely dose
Epacadostat 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03006302
NCT03006302Phase 2Completed
CompareCT.gov

Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Dec 30, 2016·Updated Oct 8, 2024

In Brief

A Phase 2 clinical trial evaluating Epacadostat, Pembrolizumab, and 3 other interventions for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy. Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207. The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Adenocarcinoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, National Cancer Institute (NCI), Incyte Corporation

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 30, 2016
Enrollment StartJan 31, 2018
Primary CompletionAug 22, 2023
Study CompletionAug 5, 2024
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 9.5 years ago

Interventions

Epacadostatdrug

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day.

Pembrolizumabdrug

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.

CRS-207biological

CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.

Cyclophosphamidedrug

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.

GVAX Pancreas Vaccinebiological

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.