Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT03006302
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03006302
Study Brief:
Protocol Section:
NCT03006302