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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT02868632
Eligibility Criteria:
Inclusion:
* Histopathological confirmation of pancreatic adenocarcinoma prior to study entry.
* Unresectable and non-metastatic disease
* At least 1 measurable metastatic lesion by RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques, or as \>10 mm with spiral computed tomography (CT) scan, and that is accessible for biopsy.
* Age \>18 years
* ECOG performance status 0-1
* Normal organ and marrow function as defined below:
Absolute Neutrophil Count \> 1,000/mcL Platelets ≥ 75,000/mcL Total Bilirubin ≤ 2 x ULN Serum Albumin ≥ 2.5 g/dl ALT or AST up to 3 x ULN if no liver metastases or ALT or AST up to 5 x ULN if liver metastases present Creatinine \< 2 x institution upper limit of normal OR Creatinine Clearance \> 45 mL/min/1.73 m2, as calculated below, for patients with creatinine levels above institutional normal
* No history of another malignancy in the past 5 years, except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma-in-situ of the cervix
* No coexisting medical problems that would limit compliance with the study
* Ability to understand and sign a written informed consent document. Patient must have willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
* Female subjects of childbearing potential must have a negative serum pregnancy test prior to study entry
* Female subjects of childbearing potential and males must agree to use a highly effective method of contraception for the duration of study treatment, and for six months after discontinuation of the study drug.
Exclusion:
* Resectable, borderline resectable or metastatic disease
* Prior chemotherapy, targeted therapy, immunotherapy, clinical trials or radiotherapy for pancreatic cancer.
* Active or history of concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies, or chronic use of systemic corticosteroids (inhaled and topical steroids are permitted)
* Active or history of chronic autoimmune disease with symptomatic disease within the 3 years before randomization.
* Active or history of inflammatory bowel disease (colitis, Crohn's disease), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea.
* Diverticulitis within the past 2 years.
* Active HIV infection
* Uncontrolled systemic disease including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Brain metastases
* Patients should not be vaccinated with live attenuated vaccines within 1 month of starting tremelimumab and MEDI4736 treatment.
* History of hypersensitivity reaction to human or mouse antibody products
* Evidence of pre-existing idiopathic pulmonary fibrosis on CT scan at baseline
* Unhealed surgical wound at time of treatment, or history of unhealed surgical wound for more than 30 days
* History of an invasive secondary primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma, prostate carcinoma treated surgically or non-melanoma skin cancer.
* Non-protocol antineoplastic agents will not be permitted during this study
* Patients may not recieve other investigational agents.
* Pregnant or lactating women
* Subjects with dementia or significantly altered mental status that would prohibit understanding or rendering of information and consent and compliance with the requirements of the protocol.
* Subjects unable or unwilling to abide by the study protocol or cooperate fully.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02868632
Study Brief:
Protocol Section:
NCT02868632