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:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT02210559
Eligibility Criteria:
Key Inclusion Criteria:
* Male, or non-pregnant and, non-lactating female
* Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
* Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per National Comprehensive Cancer Network® \[NCCN®\] criteria)
* Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted.
* Measurable disease as defined by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate liver, bone marrow, and renal function
* Agree to use contraception per protocol
* Less than Grade 2 pre-existing peripheral neuropathy
Key Exclusion Criteria:
* Prior chemotherapy or radiation for pancreatic cancer
* Solid tumor contact with superior mesenteric artery (SMA) \>180°
* Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas)
* Major surgery, within 4 weeks prior to Day 1 on study
* History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
* Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
* Uncontrolled intercurrent illness
* Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
* Current abuse of alcohol or drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02210559
Study Brief:
Protocol Section:
NCT02210559