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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT02179918
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.
* Measurable disease per RECIST v1.1.
* Adequate bone marrow, renal and liver functioning
Exclusion Criteria:
* CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.
* History of any of the following toxicities associated with a prior immunotherapy:
* Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy;
* Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy
* Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
* History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02179918
Study Brief:
Protocol Section:
NCT02179918