Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer
Verified date | January 2024 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 1, 2024 |
Est. primary completion date | August 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Merck Sharp & Dohme LLC, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recommended Dose of Epacadostat | Evaluate 4 dose levels of epacadostat, in order to determine recommended dose for use in combination with pembrolizumab, CY, GVAX, and CRS-207 | 1 year | |
Primary | 6 Month Survival | Proportion of subjects who are alive 6 months or longer after the date of randomization | 4 years | |
Secondary | Number of participants experiencing drug-related adverse events (AEs) requiring treatment discontinuation | 4 years |
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