The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical research trials for both muscle-invasive and non–muscle-invasive bladder cancers. The studies listed here are evaluating the safety and efficacy of combinations of chemotherapy and immunotherapies, both for treatment and recurrence prevention. Some trials are specifically investigating either recurrent or metastatic bladder cancer. One trial is also analyzing the benefits of a risk-adapted approach to treatment, based on a patient’s genetic mutational profile.
All of the studies described here can be found on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: Pilot Study of Celecoxib Combined With Gemcitabine and Cisplatin for Neoadjuvant Treatment of Localized, Muscle-Invasive Bladder Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Baylor College of Medicine
Purpose: To compare patient tumor tissue before and after treatment with chemotherapy plus celecoxib
Primary Outcome Measures: mRNA expression in pre- and post-chemotherapy tissues [time frame: up to 4 cycles of 21-day chemotherapy] and the number and severity of adverse events [time frame: until 30 days after last treatment]
Principal Investigator: Aihua Edward Yen, MD, Baylor College of Medicine; contact (713) 798-3750, ay04461@bcm.edu
ClinicalTrials.gov Identifier: NCT02885974
Study Title: A Phase I Single-Arm Study of the Combination of Durvalumab (MEDI4736) and Oportuzumab Monatox (VB4-845) in Subjects With High-Grade Non–Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guérin (BCG)
Study Type: Interventional/sequential assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To test whether the drugs durvalumab and oportuzumab monatox together are safe and effective for the treatment of people with non–muscle-invasive bladder cancer who had been previously treated with BCG
Primary Outcome Measures: Safety, tolerability, and a list of adverse event frequencies [time frame: 1 year]
Principal Investigator: Piyush K. Agarwal, MD, National Cancer Institute; contact Sonia E. Bellfield, RN, (240) 760-6118, sonia.bellfield@nih.gov
ClinicalTrials.gov Identifier: NCT03258593
PHASE II
Study Title: A Phase II Trial of Risk-Adapted Treatment for Muscle-Invasive Bladder Cancer After Neoadjuvant Accelerated Methotrexate, Vinblastine, Doxorubicin, and Cisplatin
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Fox Chase Cancer Center
Purpose: To evaluate a risk-adapted approach, based on mutational profiles, to the treatment of muscle-invasive bladder cancer
Primary Outcome Measures: Metastasis-free survival at 2 years [time frame: 24 months]
Principal Investigator: Daniel Geynisman, MD, Fox Chase Cancer Center; contact (215) 214-1515, Daniel.Geynisman@fccc.edu
ClinicalTrials.gov Identifier: NCT02710734
Study Title: Phase II Trial of Atezolizumab in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute/Canadian Cancer Trials Group
Purpose: To study how well atezolizumab works in treating patients with recurrent non–muscle-invasive bladder cancer that has not responded to treatment with BCG
Primary Outcome Measures: Event-free survival [time frame: from date of registration to first documentation of event, assess up to 18 months] and complete response rate in the subset of patients with carcinoma in situ [time frame: 25 weeks after registration]
Principal Investigator: Peter C. Black, MD, Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02844816
PHASE III
Study Title: Secondary Prevention Trial of Rapamycin in Patients With Resected Non–Muscle-Invasive Bladder Cancer
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: The University of Texas Health Science Center at San Antonio
Purpose: To test whether a 0.5-mg daily dose of rapamycin (also known as sirolimus) increases recurrence-free survival
Primary Outcome Measures: Recurrence-free survival [time frame: 2 years or until disease relapse]
Principal Investigator: Robert Svatek, MD, The University of Texas Health Science Center at San Antonio; contact Emily M. Rios, BA, (210) 567-3224, riose3@uthscsa.edu
ClinicalTrials.gov Identifier: NCT03298958
Study Title: Phase III Randomized Adjuvant Study of Pembrolizumab in Muscle-Invasive and Locally Advanced Urothelial Carcinomas (AMBASSADOR) Versus Observation
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study how well pembrolizumab works in treating patients with metastasized bladder cancer
Primary Outcome Measures: Overall survival [time frame: from randomization to the date of death from any cause, assessed up to 5 years] and disease-free survival [time frame: from randomization to the first metastatic recurrence or death, whichever occurs first, assessed up to 5 years]
Principal Investigator: Andrea B. Apolo, MD, Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT03244384 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
