Back to resultsA Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)
Primary Purpose
Bladder Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CDX-1307 Vaccine Regimen
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, immunotherapy, cystectomy, cancer vaccine, human chorionic gonadotropin, hCG, urogenital neoplasms, urinary bladder neoplasms, muscle invasive, non-metastatic, transitional cell (urothelial) bladder cancer
Eligibility Criteria
Inclusion Criteria:
Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
- 18 years of age or older.
- 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.
- Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible.
- Tumor tissue (obtained during a prior procedure) confirmed to express hCG-β by a central laboratory.
- 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:
- Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable.
- 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.
- 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).
- Known infection with HIV, HBV or HCV.
- 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.
Sites / Locations
- BCG Oncology, PC
- University of California - San Diego
- University of Southern California Norris Comprehensive Cancer Center LA-USC Medical Center
- University of Colorado Cancer Center
- University of Florida
- Moffitt Cancer Center
- University of Iowa Hospitals and Clinics
- University of Kentucky Markey Cancer Center Clinical Research Organization
- University of Maryland Greenebaum Cancer Center
- Henry Ford Health System
- Washington University School of Medicine
- Roswell Park Cancer Center
- Weill Cornell Medical College
- University of Rochester
- SUNY Upstate Medical University
- Syracuse VA Medical Center
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CDX-1307 Vaccine Regimen
Arm Description
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).
Outcomes
Primary Outcome Measures
2 year Recurrence-Free Survival Rate
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
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
Tumor response to neoadjuvant chemotherapy
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
Overall survival is defined as the number of months from enrollment to the date of death (whatever the cause).
Safety / Tolerability
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01094496
Brief Title
A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Portfolio prioritization due to slow enrollment
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, immunotherapy, cystectomy, cancer vaccine, human chorionic gonadotropin, hCG, urogenital neoplasms, urinary bladder neoplasms, muscle invasive, non-metastatic, transitional cell (urothelial) bladder cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDX-1307 Vaccine Regimen
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
CDX-1307 Vaccine Regimen
Intervention Description
CDX-1307 vaccine co-administered with immune adjuvants (GM-CSF, Poly-ICLC and Resiquimod)
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Primary Outcome Measure Information:
Title
2 year Recurrence-Free Survival Rate
Description
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.
Time Frame
2 years following enrollment
Title
Duration of Recurrence-Free Survival
Description
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).
Time Frame
Up-to 4 years after bladder removal surgery (cystectomy)
Secondary Outcome Measure Information:
Title
Tumor response to neoadjuvant chemotherapy
Description
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.
Time Frame
At cystectomy (anticipated to be about 4 months post-enrollment)
Title
Overall survival
Description
Overall survival is defined as the number of months from enrollment to the date of death (whatever the cause).
Time Frame
Up-to 4 years following bladder removal surgery (cystecomy)
Title
Safety / Tolerability
Description
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.
Time Frame
Through completion of study treatment (about 1 year post-resection)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
18 years of age or older.
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.
Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible.
Tumor tissue (obtained during a prior procedure) confirmed to express hCG-β by a central laboratory.
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:
Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable.
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.
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).
Known infection with HIV, HBV or HCV.
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.
Facility Information:
Facility Name
BCG Oncology, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
University of California - San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Southern California Norris Comprehensive Cancer Center LA-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky Markey Cancer Center Clinical Research Organization
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Syracuse VA Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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