Trial of bladder cancer therapy avelumab opens
Recruitment has begun for a phase III trial of avelumab in bladder cancer patients with no disease progression after completing first-line platinum-based chemotherapy. The randomized, openlabel trial will compare maintenance treatment with avelumab plus bacillus Calmette-Guerin (BCG) against BCG therapy alone to investigate their benefit in prolonging overall survival in those without disease progression on or after platinum-based therapy. Contact is Shilpa Gupta, MD. (MCC 2015IS176)
Trial of adjuvant therapy for invasive bladder cancer
Patients are sought for a study of adjuvant PD-1 inhibitor therapy nivolumab for urothelial cancer conducted at Masonic Cancer Center, University of Minnesota. The phase III randomized, double-blind study aims to determine the effectiveness and safety of nivolumab compared to placebo among participants who have had radical surgery for invasive urothelial cancer. The primary outcome measure is disease-free survival approximately 5 years after the first subject has been randomly assigned. Study contact is Gautam Jha, MD. (NCT02632409; MCC protocol 2105IS170)
Enrolling patients in trial of recombinant therapy for NMIBC
Participants are sought for a currently enrolling phase III trial investigating a gene-based therapy for non-muscleinvasive bladder cancer (NMIBC). The study will test whether a recombinant vector, rAD-IFN/Syn3 (Instiladrin®) improves delivery of and prolongs cancer cells’ exposure to interferon-alfa2b. Previous clinical studies have found the regimen safe and effective treatment for BCG-refractory and recurrent NIMBC. The current trial employs a high dose and seeks to expand earlier observations. The principal investigator at the University of Minnesota site is Badrinath Konety, MD, MBA. (NCT02773849)
Participants sought for trial of pembrolizumab
A currently enrolling phase II study will investigate pembrolizumab, a PD-1 inhibitor, as a therapy for highrisk, muscle-invasive bladder cancer unresponsive to bacillus CalmetteGuerin therapy. Study participants receiving the therapy are those with the condition who are ineligible for or have refused to undergo radical cystectomy. Masonic Cancer Center is one of 35 institutions involved in the study. The principal investigator is Shilpa Gupta, MD. (NCT02625961; MCC protocol 2015IS163)
Trial of Combination Therapy for Bladder Cancer to Open
A clinical trial enrolling this fall will evaluate the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as a neoadjuvant treatment for muscle-invasive bladder cancer (MIBC). Masonic Cancer Center, University of Minnesota serves as study sponsor and as 1 of the 3 national sites for the phase II trial. The trial therapy will be given to eligible participants prior to standard-of-care radical cystectomy, and participants will be followed for up to 2 years after cystectomy to determine progression-free survival. In addition to assessing the therapy’s safety and efficacy, researchers will evaluate molecular subtypes associated with resistance to platinum-based chemotherapy, the first-line treatment for the condition, and they will track whether the combination therapy alters this response.
Eligible participants will have a diagnosis of MIBC (predominantly urothelial carcinoma in cases of mixed histology). Clinical stage must be T2-T4a, N<1 disease (solitary lymph node measuring less than 2 cm), and M0 and deemed eligible for radical cystectomy.
Shilpa Gupta, MD, serves as site lead investigator. (NCT03294304)
After a patient’s cancer progresses on various treatments, he opts for a clinical trial immunotherapy. At 3 months of therapy, he experiences a near complete radiographic response and resolution of pain.Continue reading
While chemotherapy is the first-line treatment for advanced urothelial cancer, checkpoint inhibitors have shown success in patients with bladder cancer. Clinical trials are testing their further use.Continue reading