Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma (NCT03854474)
🩺 Plain-English Summary (8th-Grade Level)
This phase I/II trial studies the side effects and best dose of tazemetostat and how well it works when given together with pembrolizumab in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced ) or from where it first started (primary site) to other places in the body (metastatic). Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tazemetostat and pembrolizumab may work better in treating patients with urothelial carcinoma compared to pembrolizumab without tazemetostat.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (31 items) and avoid the listed exclusions (37 items).
Location: Mayo Clinic Hospital in Arizona — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with disease that is suitable for local therapy administered with curative intent are not eligible
- Patients who have had chemotherapy, targeted small molecule therapy, or radiotherapy within 4 weeks prior to entering the study are not eligible
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1 per Common Terminology Criteria for Adverse Events \[CTCAE\] v.5 ) are not eligible
- Note: patients with =\< grade 2 neuropathy or =\< grade 2 alopecia or =\< grade 3 audiometric hearing loss are an exception to this criterion and may qualify for the study
- Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Patients are not eligible who are currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
- Patients who have received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 4 weeks prior to the first dose of treatment are not eligible
- Patients with a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment are not eligible
- Note: the use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI)
- Patients with thrombocytopenia, neutropenia, or anemia of grade 3 (per CTCAE 5.0 criteria) are not eligible
- Patients with abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN, e.g. JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing are not eligible
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (34 Sites)
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona
- Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut
- Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut
- Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut
- Yale University — New Haven, Connecticut
- Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut
- Smilow Cancer Hospital-Orange Care Center — Orange, Connecticut
- Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut
- Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut
- Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut
- Mayo Clinic in Florida — Jacksonville, Florida
- Northwestern University — Chicago, Illinois
- University of Kansas Clinical Research Center — Fairway, Kansas
- HaysMed — Hays, Kansas
- Lawrence Memorial Hospital — Lawrence, Kansas
- The University of Kansas Cancer Center - Olathe — Olathe, Kansas
- University of Kansas Cancer Center-Overland Park — Overland Park, Kansas
- Mercy Hospital Pittsburg — Pittsburg, Kansas
- Salina Regional Health Center — Salina, Kansas
- University of Kansas Health System Saint Francis Campus — Topeka, Kansas
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
💰 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 § 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.