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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)

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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

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: CDX-1307 Vaccine Regimen Drug: Chemotherapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : July 2011
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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).
Biological: CDX-1307 Vaccine Regimen
CDX-1307 vaccine co-administered with immune adjuvants (GM-CSF, Poly-ICLC and Resiquimod)

Drug: Chemotherapy



Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094496


Locations
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United States, Arizona
BCG Oncology, PC
Phoenix, Arizona, United States, 85032
United States, California
University of California - San Diego
La Jolla, California, United States, 92093
University of Southern California Norris Comprehensive Cancer Center LA-USC Medical Center
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, United States, 40536-0093
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
Weill Cornell Medical College
New York, New York, United States, 10021
University of Rochester
Rochester, New York, United States, 14642
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Syracuse VA Medical Center
Syracuse, New York, United States, 13210
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Celldex Therapeutics

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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT01094496     History of Changes
Other Study ID Numbers: CDX1307-03
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: February 2016
Keywords provided by Celldex Therapeutics:
bladder cancer
immunotherapy
cystectomy
cancer vaccine
human chorionic gonadotropin
hCG
urogenital neoplasms
urinary bladder neoplasms
muscle invasive
non-metastatic
transitional cell (urothelial) bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs