Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

Phase 2

Completed

• Conditions: Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: Epacadostat; Drug: Pembrolizumab; Biological: CRS-207; Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine

• Registration Number: NCT03006302
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-30
• Study Start: 2018-01-31
• Primary Completion: 2023-08-22
• Results First Submitted: 2024-05-28
• Results First Submitted QC: 2024-05-28
• Results First Posted: 2024-06-20
• Study Completion: 2024-08-05
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-23
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2: Dose Expansion	CRS-207	Epacadostat/Pembrolizumab/CRS-207
Part 1: Dose Level 1	GVAX Pancreas Vaccine	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 2	Epacadostat	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 2	GVAX Pancreas Vaccine	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 1	Pembrolizumab	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1X: Dose Level 2	Pembrolizumab	Epacadostat/Pembrolizumab/CRS-207
Part 1: Dose Level 1	Epacadostat	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 1	CRS-207	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 1	Cyclophosphamide	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 2	Pembrolizumab	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 2	Cyclophosphamide	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1: Dose Level 2	CRS-207	Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Part 1X: Dose Level 2	Epacadostat	Epacadostat/Pembrolizumab/CRS-207
Part 1X: Dose Level 2	CRS-207	Epacadostat/Pembrolizumab/CRS-207
Part 1X: Dose Level 3	Epacadostat	Epacadostat/Pembrolizumab/CRS-207
Part 1X: Dose Level 3	Pembrolizumab	Epacadostat/Pembrolizumab/CRS-207
Part 2: Dose Expansion	Pembrolizumab	Epacadostat/Pembrolizumab/CRS-207
Part 1X: Dose Level 3	CRS-207	Epacadostat/Pembrolizumab/CRS-207
Part 2: Dose Expansion	Epacadostat	Epacadostat/Pembrolizumab/CRS-207

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Epacadostat	9 weeks	Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
6 Month Survival	6 months	Number of subjects who are alive 6 months or longer after the date of first treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation	15 months

Trial Locations

Locations (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States