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

NCT ID: NCT01441765

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-07-31

Brief Summary

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.

Detailed 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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT-011

CT-011 3 mg/kg for 4 cycles of 6 weeks

Group Type: ACTIVE_COMPARATOR

CT-011

Intervention Type: DRUG

CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks

CT-011 with DC/RCC fusion vaccine

CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion

Group Type: ACTIVE_COMPARATOR

CT-011

Intervention Type: DRUG

CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks

DC/RCC fusion vaccine

Intervention Type: BIOLOGICAL

Vaccination once per cycle on Day 8 of treatment cycles 2-4

Interventions

CT-011

CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks

Intervention Type: DRUG

DC/RCC fusion vaccine

Vaccination once per cycle on Day 8 of treatment cycles 2-4

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Avigan, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Avigan, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P50CA101942-06A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-178

Identifier Type: -

Identifier Source: org_study_id