A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)
NCT ID: NCT01094496
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2010-04-30
2011-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
CDX-1307 Vaccine Regimen
CDX-1307 vaccine co-administered with immune adjuvants (GM-CSF, Poly-ICLC and Resiquimod)
Chemotherapy
Interventions
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CDX-1307 Vaccine Regimen
CDX-1307 vaccine co-administered with immune adjuvants (GM-CSF, Poly-ICLC and Resiquimod)
Chemotherapy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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BCG Oncology, PC
Phoenix, Arizona, United States
University of California - San Diego
La Jolla, California, United States
University of Southern California Norris Comprehensive Cancer Center LA-USC Medical Center
Los Angeles, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Rochester
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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CDX1307-03
Identifier Type: -
Identifier Source: org_study_id
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