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A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094496
Recruitment Status : Terminated (Portfolio prioritization due to slow enrollment)
First Posted : March 29, 2010
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date March 15, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
  • 2 year Recurrence-Free Survival Rate [ Time Frame: 2 years following enrollment ]
    The 2-year recurrence-free survival rate will be estimated based on the proportion of patients who are classified as alive and without documented disease recurrence at this time point.
  • Duration of Recurrence-Free Survival [ Time Frame: Up-to 4 years after bladder removal surgery (cystectomy) ]
    The duration of recurrence-free survival is defined as the number of months from enrollment to the earlier of disease recurrence or death (whatever the cause).
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
2 year Recurrence-Free Survival [ Time Frame: 2 years following randomization ]
The 2-year recurrence-free survival rate will be estimated for each treatment arm based on the proportion of patients who are classified as alive and without documented disease recurrence at this time point.
Change History Complete list of historical versions of study NCT01094496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
  • Tumor response to neoadjuvant chemotherapy [ Time Frame: At cystectomy (anticipated to be about 4 months post-enrollment) ]
    The tumor response to neoadjuvant chemotherapy will be evaluated as the proportion of patients who achieve a radiographic response as defined by the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) or a pathologic complete response at cystectomy.
  • Overall survival [ Time Frame: Up-to 4 years following bladder removal surgery (cystecomy) ]
    Overall survival is defined as the number of months from enrollment to the date of death (whatever the cause).
  • Safety / Tolerability [ Time Frame: Through completion of study treatment (about 1 year post-resection) ]
    The number and percentage of patients experiencing one or more adverse events will be summarized by relationship to study drug and severity. Separate tabulations will be provided for the neoadjuvant and adjuvant treatment phases.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
  • Objective response rate [ Time Frame: Following neoadjuvant chemotherapy (usually 3 months following randomization) ]
    The objective response rate (ORR) will be the proportion of patients who achieve radiographic partial or complete response (PR or CR) preoperatively, as determined by RECIST.
  • Pathological complete response rate [ Time Frame: At cystectiomy (anticipated to be about 4 months post-randomization) ]
    The proportion of patients who achieve a pathologic complete response at cystectomy.
  • Overall survival [ Time Frame: Up-to 4 years post-randomization ]
    Overall survival is defined as the number of months from randomization to the date of death (whatever the cause.
  • Safety / Tolerability [ Time Frame: Through completion of study treatment (about 1 year post-resection) ]
    The number and percentage of patients experiencing one or more AEs will be summarized by treatment arm, relationship to study drug, and severity. Separate tabulations will be provided for the neoadjuvant and adjuvant treatment phases.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)
Official Title  ICMJE A Phase II, Open-Label Study of the CDX-1307 Vaccine Regimen as Neoadjuvant and Adjuvant Therapy in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer Expressing hCG-β
Brief Summary The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine regimen when it is given before and after bladder cancer surgery. The study will also provide information about the safety of the vaccine regimen when given in combination with chemotherapy, and how it affects the immune systems.
Detailed Description

CDX-1307 is an experimental vaccine that is designed to generate an immune response against a protein called human chorionic gonadotropin-beta (hCG-β). hCG-β is made by several types of cancers, including bladder cancer, and has been shown to be associated with shorter times to development of metastases and reduced survival in bladder cancer. In this study, it is hoped that administering the CDX-1307 vaccine will cause the body's immune system to attack bladder cancer cells in order to kill them or otherwise keep them from spreading or coming back.

Standard treatment for early stage, muscle invasive bladder cancer includes the administration of chemotherapy to shrink the tumor followed by surgical removal of the bladder (cystectomy).

This study will compare the effect of adding CDX-1307 administration to this standard treatment. CDX-1307 will be given with 3 different immune stimulants to try to increase the immune response against the tumor cells; collectively, this is called the "CDX-1307 vaccine regimen."

Only patients whose tumors make the hCG-β protein will be included in this study. Eligible patients will receive "standard of care" chemotherapy with the CDX-1307 vaccine regimen before surgery, and then CDX-1307 vaccine regimen alone (without chemotherapy) after surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • Biological: CDX-1307 Vaccine Regimen
    CDX-1307 vaccine co-administered with immune adjuvants (GM-CSF, Poly-ICLC and Resiquimod)
  • Drug: Chemotherapy
Study Arms  ICMJE Experimental: CDX-1307 Vaccine Regimen
Chemotherapy with CDX-1307 vaccine regimen (neoadjuvant phase), followed by bladder removal surgery (cystectomy). CDX-1307 vaccine regimen will continue to be given for up-to 1 year post-surgery (adjuvant/long-term follow-up phase).
Interventions:
  • Biological: CDX-1307 Vaccine Regimen
  • Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 2, 2011)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2010)
60
Estimated Study Completion Date  ICMJE October 2017
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:

  1. 18 years of age or older.
  2. Newly diagnosed muscle-invasive transitional cell (urothelial) bladder cancer where neoadjuvant chemotherapy and radical cystectomy with curative intent are indicated (i.e., American Joint Committee on Cancer (AJCC) stage T2-4a, Nany, M0). Patients must be entered into the study within eight weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy or transurethral resection of bladder tumor (TURBT) procedure.
  3. Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible.
  4. Tumor tissue (obtained during a prior procedure) confirmed to express hCG-β by a central laboratory.
  5. Candidate for therapy with neoadjuvant chemotherapy.

Exclusion Criteria:

Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:

  1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable.
  2. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions to imiquimod, resiquimod, or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
  3. Concurrent chronic treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted).
  4. Known infection with HIV, HBV or HCV.
  5. Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or would contraindicate receipt of neoadjuvant chemotherapy or surgical resection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094496
Other Study ID Numbers  ICMJE CDX1307-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celldex Therapeutics
Study Sponsor  ICMJE Celldex Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Celldex Therapeutics
Verification Date February 2016

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