Clinical Trials Offer Hope for Bladder Cancer Patients

Cleveland Clinic researchers are conducting new clinical trials with the goal of improving treatment outcomes and quality of life for patients with bladder cancer. One trial could change how neoadjuvant chemotherapy is selected; the other could change how physicians treat patients with platinum-refractory advanced/metastatic urothelial cancer.

The SWOG Neoadjuvant Trial

The SWOG neoadjuvant trial is a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer. It is open to cisplatin-eligible patients (gemcitabine/cisplatin vs. dose-dense methotrexate/vinblastine/adriamycin/cisplatin [MVAC]).

“This trial aims to evaluate the predictive value of the COXEN signature in regard to a neoadjuvant chemotherapy regimen,” says Cleveland Clinic oncologist Petros Grivas, MD, PhD. “The overarching goal is to incorporate molecular predictors of response to clinical practice. For example, if a significant correlation is found between COXEN signature and response to each chemotherapy regimen, and this is further validated in a future trial, it may change the way that neoadjuvant chemotherapy is selected.”

The Mocetinostat Trial

The mocetinostat trial is for patients with platinum-refractory advanced/metastatic urothelial cancer, for which no standard therapies are available. “This trial is an open-label, single-arm, phase II study of mocetinostat in patients with an inactivating mutation or deletion of one or two chromatin remodeling genes in their tumors, who have been previously treated with platinum for locally advanced or metastatic urothelial carcinoma,” says Dr. Grivas. “This type of molecular-based trial has been long anticipated, considering the very limited treatment options for this disease and the urgent need for more therapies. If this therapy proves to be safe and effective, it may change the way we treat platinum-resistant metastatic/advanced urothelial carcinoma by utilizing new molecular targets and biomarkers.”

Other Clinical Trials

Cleveland Clinic is conducting (or will soon initiate) several additional bladder cancer clinical trials for various disease modalities (e.g., high-risk non muscle-invasive bladder cancer, first-line for cisplatin-ineligible patients with advanced disease, second-line and subsequent therapies for patients with advanced disease). “Three very promising immunotherapy trials will also be opening soon, in addition to a currently open trial with anti-PDL1 immune checkpoint inhibitor,” Dr. Grivas says. “There is also another potential clinical trial in the works for patients with advanced/metastatic disease.”

About the Bladder Cancer Program

Cleveland Clinic’s bladder cancer program uses a multifaceted and comprehensive approach that unites basic scientists and translational and clinical researchers to develop and evaluate new treatments for patients with bladder cancer. Multidisciplinary tumor boards discuss challenging clinical cases and a monthly research meeting is held to design and review transformative research. The program operates a database for clinical, radiological and pathological data collection and is revamping its bladder cancer biorepository.

Cleveland Clinic’s bladder cancer program participates in cooperative oncology groups (e.g., ECOG-ACRIN, SWOG, RTOG), as well as the Bladder Cancer Advocacy Network and the International Bladder Cancer Network. The program collaborates with other major U.S. and international institutions to develop new therapies for patients.

Clinical Trials Referrals

If you have patients who might be candidates for any of these clinical trials, contact research nurses Allison Tyler (tylera2@ccf.org) or Pam Profusek (profusp@ccf.org).

Photo Credit © Russell Lee