A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)
|ClinicalTrials.gov Identifier: NCT01094496|
Recruitment Status : Terminated (Portfolio prioritization due to slow enrollment)
First Posted : March 29, 2010
Last Update Posted : March 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Biological: CDX-1307 Vaccine Regimen Drug: Chemotherapy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094496
|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|