Phase II Study of PD-1 Blockade Alone or In Conjunction With the Dendritic Cell (DC)/Renal Cell Carcinoma (RCC) Fusion Cell Vaccination
18 Years
N/A
Both
Renal Cell Carcinoma
Trial Information
Phase II Study of PD-1 Blockade Alone or In Conjunction With the Dendritic Cell (DC)/Renal Cell Carcinoma (RCC) Fusion Cell Vaccination
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with adverse events
Outcome Description:
To assess the toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction iwth DC/RCC
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
David Avigan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
11-178
NCT ID:
NCT01441765
Start Date:
November 2011
Completion Date:
Related Keywords:
- Renal Cell Carcinoma
- Kidney
- Metastatic
- Stage IV
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
