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Cancer Vaccine
CDX-1307 Vaccine Regimen for Bladder Cancer
Phase 2
Waitlist Available
Research Sponsored by Celldex Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up-to 4 years after bladder removal surgery (cystectomy)
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Bladder Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up-to 4 years after bladder removal surgery (cystectomy)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up-to 4 years after bladder removal surgery (cystectomy)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
2 year Recurrence-Free Survival Rate
Duration of Recurrence-Free Survival
Secondary study objectives
Overall survival
Safety / Tolerability
Tumor response to neoadjuvant chemotherapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CDX-1307 Vaccine RegimenExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
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Who is running the clinical trial?
Celldex TherapeuticsLead Sponsor
64 Previous Clinical Trials
5,814 Total Patients Enrolled
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