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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cyclophosphamide; Pancreatin; Pancrelipase; Pembrolizumab; Vaccines

Criteria

Inclusion Criteria (abbreviated):

• Documented adenocarcinoma of the pancreas

• Have disease progression after prior chemotherapy for metastatic pancreas cancer (or adjuvant or neoadjuvant if progression occurred within 6 months of completing this regimen)

• Presence of at least one measurable lesion

• Patient acceptance to have a tumor biopsy of an accessible lesion at 2 time points (baseline and on study)

• ECOG performance status of 0 or 1

• Life expectancy of greater than 3 months

• Adequate organ and marrow function defined by study-specified laboratory tests

Exclusion Criteria (abbreviated):

• Brain metastases

• Clinical or radiographic ascites (some trace amount may be allowed)

• Rapidly progressing disease

• Live vaccine within 30 days of study treatment (flu vaccine allowed)

• Surgery within 28 days of study treatment (some exceptions for minor procedures)

• Use of an investigational agent or device within 28 days of study treatment.

• Chemotherapy, radiation, or biological cancer therapy within 14 days of study treatment.

• Prior treatment with anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD-L2, or with IDO inhibitor.

• Use of growth factors within 14 days of study treatment

• Use of any systemic steroids within 14 days of study treatment or other immunosuppressive agents within 7 days of study treatment.

• Use of more than 2 g/day of acetaminophen

• Use of any UGT1A9 inhibitor

• Use of warfarin

• Use of MAOIs or drugs with significant MAOI activity within the 21 days of screening

• History of Seratonin Syndome

• Known allergy to both penicillin and sulfa

• Known or suspected hypersensitivity to any monoclonal antibody or any study drug component

• Have artificial joints or implants that cannot be easily removed or a history of infection associated with an implant

• Significant or malignant pleural effusion

• New pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study enrollment

• History of autoimmune disease (exceptions for Graves or Hashimoto's disease, vitiligo, and type I diabetes mellitus)

• Gastrointestinal condition that may affect drug absorption

• Significant heart disease or heart disease requiring antibiotic for prevention of endocarditis

• History of abnormal electrocardiogram (ECG) that is deemed meaningful by the investigator

• History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis

• Pulse oximetry of < 92% on room air or the need for supplemental home oxygen

• Infection with HIV, hepatitis B or hepatitis C

• Other conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access that would affect the patient's ability to comply with study visits and procedures

• Pregnant or breastfeeding women

• Unwillingness or inability to follow the study schedule for any reason