Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer (NCT03978624)
Window of Opportunity Platform Study to Define Immunogenomic Changes With Pembrolizumab Alone and in Rational Combinations in Muscle-Invasive Bladder Cancer
๐ฉบ Plain-English Summary (8th-Grade Level)
This is an open-label, window of opportunity platform study for subjects with muscle-invasive bladder cancer (MIBC) who are deemed ineligible or refuse cisplatin-based neoadjuvant chemotherapy and are scheduled to undergo definitive surgery (radical cystectomy), or are planning to undergo trimodality therapy (maximal transurethral resection of the bladder tumor followed by concurrent chemoradiation). The primary objective of this study is to assess changes to immunogenomic markers after treatment with pembrolizumab alone and in combination with the selective class I histone deacetylase (HDAC) inhibitor (entinostat).
Who can join: Review the eligibility criteria below.
Location: Lineberger Comprehensive Cancer Center โ Chapel Hill, North Carolina
Age range: 18 Years to 99 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Lineberger Comprehensive Cancer Center โ Chapel Hill, North Carolina
- Fox Chase Cancer Center โ Philadelphia, Pennsylvania
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bladder Cancer
- Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer โ St Louis, Missouri
- Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer โ Calgary, Alberta
- Determinants of Bladder Cancer Recurrence Study (The DETER Study) โ Basking Ridge, New Jersey
- Quality of Life in Patients With Bladder Cancer โ New York, New York
- A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer โ Hartford, Connecticut
- A Diagnostic for the Early Detection of Bladder Cancer โ Long Beach, California
Explore by condition: All Bladder Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.