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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT02482168
Eligibility Criteria:
Key Inclusion Criteria:
* Histologically documented diagnosis of solid tumor
* For subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high)
* No known effective therapy options are available
* Measurable disease by RECIST 1.1
* ECOG performance status of 0 or 1
* Adequate bone marrow, liver and kidney function
* No toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy
* Negative pregnancy test for women of child bearing potential
Key Exclusion Criteria:
* Any history of or current hematologic malignancy
* Major surgery or treatment with any other investigational agent within 4 weeks
* Uncontrolled diabetes or hypertension
* History of arterial thromboembolic event
* History of congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction
* Active known clinically serious infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02482168
Study Brief:
Protocol Section:
NCT02482168