Clinical trial · Interventional
Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer
Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRS-207 | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epacadostat | Drug | — | UNRESOLVED |
| GVAX Pancreas Vaccine | Biological | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Level 1
- description
- Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
- interventionNames
- Drug: Epacadostat
- Drug: Pembrolizumab
- Biological: CRS-207
- Drug: Cyclophosphamide
- Biological: GVAX Pancreas Vaccine
- type
- EXPERIMENTAL
- label
- Part 1: Dose Level 2
- description
- Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
- interventionNames
- Drug: Epacadostat
- Drug: Pembrolizumab
- Biological: CRS-207
- Drug: Cyclophosphamide
- Biological: GVAX Pancreas Vaccine
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available