E-news Newsletter - October 2020
Spotlight on Alliance Trials


Alliance Trial Studies Immunotherapy in Treating Patients with Invasive Bladder Cancer

Alliance A031803: Phase II trial o intravesical gemcitabine and MK-3475 (pembrolizumab) in the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer

Michael Woods, MD, of Loyola University Medical Center, is leading Alliance A031803, a phase II trial that studies how well gemcitabine together with pembrolizumab works in treating patients with non-muscle invasive bladder cancer (NMIBC) who are unresponsive to the bacillus Calmette-Guérin (BCG) vaccine. 

NMIBC accounts for about 70 percent of all bladder cancer and is associated with a more than 88 percent survival rate over five years. Despite significant advances in the management of NMIBC, it remains associated with significant morbidity and mortality due to its tendency to recur and progress to muscle-invasive or systemic disease. This trial may have a significant impact on future research. The results of this trial may provide a novel treatment approach to this patient population and support the importance of additional research combining intravesical therapy (injecting drug directly into the bladder) with immune checkpoint inhibition. Conversely, the results may direct urologic research toward different combinations of therapies for BCG-unresponsive non-muscle invasive bladder cancer.

This trial’s primary objective is two-fold: 1) to estimate the six-month complete response rate of treatment with intravesical gemcitabine in combination with pembrolizumab in patients with BCG-unresponsive NMIBC who have a carcinoma in situ (CIS) component, and 2) to estimate the 18-month event-free survival rate for all patients with BCG-unresponsive NMIBC receiving intravesical gemcitabine in combination with pembrolizumab. 

All patients will receive induction therapy, including gemcitabine intravesically weekly during cycles 1 and 2 and pembrolizumab intravenously every three weeks during cycles 1-4). One cycle lasts for three weeks. After induction therapy, treatment will be determined based on patient’s response. If no evidence of disease, patients will receive maintenance therapy, including gemcitabine intravesically week 1 of each cycle for cycles 5-16 and pembrolizumab intravenously week 1 of each cycle for cycles 5-16. Treatment will continue until disease recurrence or progression or unacceptable side effects. Patients will be followed for five years from registration. 

For complete information on the trial design, treatment plan, and patient eligibility, refer to the study protocol, which can be found on the Alliance website or the CTSU website.  

Study Chair: Michael Woods, MD, Loyola University Medical Center | Email: michael.woods@lumc.edu
Activated: 1/06/2020 | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA031803


For other articles in this issue of Alliance E-News, see below.