PD-1 Alone or With Dendritic Cell/Renal Cell Carcinoma Fusion Cell Vaccine

Status: Recruiting
Phase: Phase 2
Diagnosis: Kidney Cancer
NCT ID: NCT01441765 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-178

 

CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug that are known to target specific cells (in this case, cells in the immune system) The DC RCC Vaccine is agent that tries to help the immune system to recognize and fight against cancer cells. The purpose of this research study is to determine the safety of CT-011 alone, and in combination with the Dendritic Cell Renal Cell Carcinoma (DC RCC) vaccine. The investigators are also trying to find out what effect the combination has on the disease, and on your immune system.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center

Overall PI:
David Avigan, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Stage IV renal cancer - Measurable disease - Life expectancy > 3 months - Adequate organ and marrow function Exclusion Criteria: - Prior systemic therapy for RCC - Clinical evidence of central nervous system (CNS) disease - Clinically significant autoimmune disease - HIV+ - Serious intercurrent illness such as infection requiring intravenous (IV) antibiotics, or significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure - Pregnant or lactating - History of clinically significant venous thromboembolism
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