Study Stopped
Portfolio prioritization due to slow enrollment
A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)
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
1 other identifier
interventional
3
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 29, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFebruary 13, 2020
February 1, 2016
1.2 years
March 25, 2010
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
2 years following enrollment
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).
Up-to 4 years after bladder removal surgery (cystectomy)
Secondary Outcomes (3)
Tumor response to neoadjuvant chemotherapy
At cystectomy (anticipated to be about 4 months post-enrollment)
Overall survival
Up-to 4 years following bladder removal surgery (cystecomy)
Safety / Tolerability
Through completion of study treatment (about 1 year post-resection)
Study Arms (1)
CDX-1307 Vaccine Regimen
EXPERIMENTALChemotherapy 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
CDX-1307 vaccine co-administered with immune adjuvants (GM-CSF, Poly-ICLC and Resiquimod)
Eligibility Criteria
You may qualify if:
- Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
BCG Oncology, PC
Phoenix, Arizona, 85032, United States
University of California - San Diego
La Jolla, California, 92093, United States
University of Southern California Norris Comprehensive Cancer Center LA-USC Medical Center
Los Angeles, California, 90033, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
University of Florida
Gainesville, Florida, 32610, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, 40536-0093, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Roswell Park Cancer Center
Buffalo, New York, 14263, United States
Weill Cornell Medical College
New York, New York, 10021, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Syracuse VA Medical Center
Syracuse, New York, 13210, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2010
First Posted
March 29, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
February 13, 2020
Record last verified: 2016-02