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

This study has been terminated.
(Funding)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Avigan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01441765
First received: September 22, 2011
Last updated: December 15, 2016
Last verified: December 2016

September 22, 2011
December 15, 2016
November 2011
July 2016   (Final data collection date for primary outcome measure)
  • Number of Participants With Adverse Events [ Time Frame: 2 years ]
    Assessment of toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction with DC/RCC. Toxicity was assessed and classified according to CTCAE Version 4.0.
  • Number of Participants With PR or CR at 2 Years [ Time Frame: 2 years ]
    To evaluate the complete and partial response rate following completing 4 cycles of CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, (with an absolute increase of at least 5 mm), or the appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."
  • Number of Participants With Adverse Events [ Time Frame: 2 years ]
    To assess the toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction iwth DC/RCC
  • Response Rate [ Time Frame: 2 years ]
    To evaluate the complete and partial response rate following completing 4 cycles of CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.
Complete list of historical versions of study NCT01441765 on ClinicalTrials.gov Archive Site
  • Immunologic Response [ Time Frame: 2 years ]
    To evaluate immunologic response directed against RCC and tumor specific antigens following therapy with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Immunologic response will be characterized as peak response post-therapy and ongoing response at 3 and 6 months following treatment.
  • Effect on Circulating Regulatory T Cells [ Time Frame: 2 years ]
    To evaluate the effect of CT-011 alone or in conjunction with DC/RCC fusions on circulating regulatory T cells and PD-1 expression by circulating and bone marrow derived T cells.
  • Number of Participants Who Survived at 2 Years [ Time Frame: 2 years ]
    To evaluate overall survival following treatment with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.
  • Immunologic Response [ Time Frame: 2 years ]
    To evaluate immunologic response directed against RCC and tumor specific antigens following therapy with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Immunologic response will be characterized as peak response post-therapy and ongoing response at 3 and 6 months following treatment.
  • Effect on Circulating Regulatory T Cells [ Time Frame: 2 years ]
    To evaluate the effecto of CT-011 alone or in conjunction with DC/RCC fusions on ciruclating regulatory T cells and PD-1 expression by circulating and bone marrow derived T cells.
  • Overall Survival [ Time Frame: 2 years ]
    To evaluate overall survival following treatment with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.
Not Provided
Not Provided
 
PD-1 Alone or With Dendritic Cell/Renal Cell Carcinoma Fusion Cell Vaccine
Phase II Study of PD-1 Blockade Alone or In Conjunction With the Dendritic Cell (DC)/Renal Cell Carcinoma (RCC) Fusion Cell Vaccination

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Drug: CT-011
    CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
  • Biological: DC/RCC fusion vaccine
    Vaccination once per cycle on Day 8 of treatment cycles 2-4
  • Active Comparator: CT-011
    CT-011 3 mg/kg for 4 cycles of 6 weeks
    Intervention: Drug: CT-011
  • Active Comparator: 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
    Interventions:
    • Drug: CT-011
    • Biological: DC/RCC fusion vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
July 2016
July 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01441765
11-178
P50CA101942-06A1 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Not Provided
Not Provided
David Avigan, MD, Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: David Avigan, MD Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP