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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
Results First Received: July 28, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Cell Carcinoma
Interventions: Drug: CT-011
Biological: DC/RCC fusion vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CT-011

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

CT-011: 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

CT-011: 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


Participant Flow:   Overall Study
    CT-011   CT-011 With DC/RCC Fusion Vaccine
STARTED   11   0 [1] 
COMPLETED   10   0 [1] 
NOT COMPLETED   1   0 
Death                1                0 
[1] not opened



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CT-011

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

CT-011: 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

CT-011: 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

Total Total of all reporting groups

Baseline Measures
   CT-011   CT-011 With DC/RCC Fusion Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   0   11 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%         0   0.0% 
Between 18 and 65 years      6  54.5%         6  54.5% 
>=65 years      5  45.5%         5  45.5% 
Age 
[Units: Years]
Mean (Full Range)
 63 
 (43 to 78) 
    63 
 (43 to 78) 
Gender 
[Units: Participants]
Count of Participants
     
Female      3  27.3%         3  27.3% 
Male      8  72.7%         8  72.7% 
Region of Enrollment 
[Units: Participants]
     
United States   11      11 


  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 2 years ]

2.  Primary:   Number of Participants With PR or CR at 2 Years   [ Time Frame: 2 years ]

3.  Secondary:   Immunologic Response   [ Time Frame: 2 years ]

4.  Secondary:   Effect on Circulating Regulatory T Cells   [ Time Frame: 2 years ]

5.  Secondary:   Number of Participants Who Survived at 2 Years   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to lack of funding, the study was terminated early without completing enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. David Avigan, Principal Investigator
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-9920
e-mail: davigan@bidmc.harvard.edu



Responsible Party: David Avigan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01441765     History of Changes
Other Study ID Numbers: 11-178
P50CA101942-06A1 ( US NIH Grant/Contract Award Number )
Study First Received: September 22, 2011
Results First Received: July 28, 2016
Last Updated: December 15, 2016