This trial is active, not recruiting.

Condition renal cell carcinoma
Treatments ct-011, dc/rcc fusion vaccine
Phase phase 2
Target PD-1
Sponsor Beth Israel Deaconess Medical Center
Collaborator National Institutes of Health (NIH)
Start date November 2011
End date September 2016
Trial size 44 participants
Trial identifier NCT01441765, 11-178, P50CA101942-06A1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
CT-011 3 mg/kg for 4 cycles of 6 weeks
CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
(Active Comparator)
CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
dc/rcc fusion vaccine
Vaccination once per cycle on Day 8 of treatment cycles 2-4

Primary Outcomes

Number of participants with adverse events
time frame: 2 years
Response Rate
time frame: 2 years

Secondary Outcomes

Immunologic Response
time frame: 2 years
Effect on Circulating Regulatory T cells
time frame: 2 years
Overall Survival
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Stage IV renal cancer - Measurable disease - Life expectancy > 3 months - Adequate organ and marrow function Exclusion Criteria: - Clinical evidence of central nervous system (CNS) disease. Subjects with a history of treated brain metastasis must be stable with no evidence of disease for 3 months - 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 (For Cohort 2)

Additional Information

Official title Phase II Study of PD-1 Blockade Alone or In Conjunction With the Dendritic Cell (DC)/Renal Cell Carcinoma (RCC) Fusion Cell Vaccination
Principal investigator David Avigan, MD
Description This study is divided into 2 groups. The first 22 subjects will be in Group 1 and will receive CT-011 only. The next 22 subjects will be in Group 2 and will receive CT-011 and the DC RCC vaccine. Group 1: Subjects in this cohort are not required to have tumor resection (nephrectomy) to participate in this study. For subjects who are undergoing nephrectomy and for subjects undergoing resection for another metastasis, infusions of CT-011 will begin 21 to 35 days post-surgery. Subjects will receive 4 cycles of CT-011 therapy. Each cycle consists of a dose of CT-011 given on days 1, 14, and 28 intravenously. For subjects who are not undergoing nephrectomy for standard of care therapy, infusions of CT-011 will begin 21 to 28 days following registration on the study. Subjects will receive a total of four cycles of CT-011 therapy. Each cycle consists of a dose of CT-011 given on days 1, 14, and 28 intravenously. Group 2: Subjects in this cohort will have chosen to undergo a "debulking nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells in your body) as a standard treatment for kidney cancer or have tumor lesions that are accessible (may be removed without major surgery) and are being removed to treat or diagnose their cancer. All subjects in this group will receive infusions of CT-011 21 to 35 days following tumor resection. Subjects will receive a total of 4 cycles of CT-011 therapy. Each cycle consists of a dose of CT-011 given on days 1, 14, and 28. In addition they will receive a vaccination of the DC RCC vaccine on day 8 of each cycle.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.