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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT02596035
Eligibility Criteria:
Inclusion Criteria:
* Advanced or Metastatic renal cell carcinoma (RCC)
* Predominant clear cell histology:
1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
2. No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
* Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
* Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
* Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
* All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed
Exclusion Criteria:
* Subjects with any active autoimmune disease or a history of known autoimmune disease
* History of severe hypersensitivity reaction to other monoclonal antibodies
* Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
* Known HIV or AIDS-related illness
* Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection
Other protocol-defined inclusion/exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02596035
Study Brief:
Protocol Section:
NCT02596035