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Phase II Study of PD-1 Blockade Alone or In Conjunction With the Dendritic Cell (DC)/Renal Cell Carcinoma (RCC) Fusion Cell Vaccination


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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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 CenterBoston, Massachusetts  02215