Select Ongoing Trials Currently Enrolling Patients with Bladder Cancer

December 2016, Vol 6, No 12 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with bladder cancer for inclusion in investigations of new therapies and new regimens of existing treatments for patients with bladder cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Atezolizumab as Adjuvant Therapy in Patients with Bladder Cancer After Cystectomy

The purpose of this multicenter, open-label, phase 3 clinical trial is to evaluate the safety and efficacy of using atezolizumab compared with observation as adjuvant therapy in patients with PD-L1–selected, muscle-invasive bladder cancer who are at high risk for recurrence after cystectomy. Patients aged ≥18 years with histologically or cytologically confirmed muscle-invasive transitional-cell carcinoma of the bladder, and an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive atezolizumab or observation.

The primary outcome measure is disease-free survival. The secondary outcome measures include overall survival (OS), disease-specific survival, and distant metastasis-free survival. This study plans to enroll 700 patients at multiple locations across the United States and abroad. For more information, contact 888-662-6728 or global.rochegenentechtrials@roche.com. The NLM Identifier is NCT02450331.

2 Safety and Pharmacology of Atezolizumab Alone or in Combination with Bacillus Calmette-Guérin for Patients with High-Risk, Nonmuscle-Invasive Bladder Cancer

The purpose of this nonrandomized, open-label, phase 1b/2 clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immuno­genicity, patient-reported outcomes, and preliminary antitumor activity of intravenous (IV) atezolizumab as monotherapy or in combination with intravesical Bacillus Calmette-Guérin (BCG) for the treatment of patients with high-risk nonmuscle-invasive bladder cancer. Patients aged ≥18 years with histologically confirmed high-risk nonmuscle-invasive transitional-cell carcinoma of the bladder and an ECOG performance status score of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will be grouped into 4 experimental cohorts based on the response to BCG therapy and will receive atezolizumab plus BCG.

The primary outcome measures are the proportion of patients who have adverse events, and the percentage of those who have a complete response. The secondary outcome measures include the duration of OS, maximum and minimum serum atezolizumab concentrations, and progression-free survival (PFS). This study plans to enroll 70 patients at multiple locations across the United States. For more information, contact 888-662-6728 or global.rochegenentechtrials@roche.com. The NLM Identifier is NCT02792192.

3 Efficacy and Safety of Pembrolizumab for Patients with High-Risk Nonmuscle-Invasive Bladder Cancer

The purpose of this single-group, open-label, phase 2 clinical trial is to evaluate the safety and efficacy of using pembrolizumab for the treatment of patients with high-risk, nonmuscle-invasive bladder cancer that did not respond to therapy with BCG. Patients aged ≥18 years with histologically confirmed high-risk nonmuscle-invasive transitional-cell carcinoma of the bladder and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive IV pembrolizumab 200 mg every 3 weeks for a maximum of 24 months.

The primary outcome measures are the rates of disease-free survival and complete response. The secondary outcome measure is the duration of response. This study plans to enroll 260 patients at multiple locations across the United States and abroad. For more information, call 888-577-8839. The NLM Identifier is NCT02625961.

4 ABI-009 for Patients with Nonmuscle-Invasive Transitional-Cell Bladder Cancer

The purpose of this single-group, open-label, phase 1/2 clinical trial is to evaluate the safety and antitumor activity of ABI-009 as a therapy for patients with nonmuscle-invasive bladder cancer, and to determine the appropriate dosing of ABI-009 in this patient population. Patients aged ≥18 years with a confirmed diagnosis of nonmuscle-invasive recurrent bladder cancer that is refractory to BCG and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive treatment with ABI-009.

The primary outcome measures are safety and tolerability, measured by the number of patients with adverse events. The secondary outcome measure is efficacy, measured by the number of patients who achieve a complete response. This study plans to enroll 40 patients at the Columbia University Medical Center, New York, and the Vanderbilt University Medical Center, Nashville, TN. For more information, contact Ifeanyi Onyeji at ico2106@cumc.columbia.edu, or Pamela Steele, RN, BSN, CCRC, at 615-343-2120 or pamela.steele@vanderbilt.edu. The NLM Identifier is NCT02009332.

5 Enzalutamide plus Gemcita­bine and Cisplatin for the Treatment of Patients with Bladder Cancer

The objective of this single-group, open-label, phase 1 clinical trial is to determine the dose of enzalutamide that can safely be administered in combination with gemcitabine and cisplatin to patients with advanced bladder cancer. Adverse events associated with the combination of these drugs will also be assessed, as will the effect of the combination therapy on tumors. Patients aged ≥18 years who have cytologically or histologically confirmed transitional-cell carcinoma of the bladder and an ECOG performance status score of ≤2 may be eligible for enrollment if other criteria are met. All eligible patients will be given enzalutamide plus gemcitabine and cisplatin.

The primary outcome measure is the maximum tolerated dose of enzalutamide when the drug is administered with cisplatin and gemci­tabine at standard doses. The secondary outcome measures are the overall response rate, PFS, and OS. This study plans to enroll 24 patients at the H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, and the University of Minnesota Masonic Cancer Center, Minneapolis, MN. For more information, contact Jingsong Zhang, MD, PhD, at 813-745-1363 or jingsong.zhang@moffitt.org, or Shilpa Gupta, MD, at 612-626-3003 or guptash@umn.edu. The NLM Identifier is NCT02300610.

6 Celecoxib in Combination with Gemcitabine and Cisplatin for Patients with Localized, Muscle-Invasive Bladder Cancer

The objective of this single-group, open-label, phase 1 clinical trial is to compare tumor tissue in patients with bladder cancer before and after treatment with chemotherapy plus celecoxib, including the assessment of gene expression, to see what effect celecoxib may have on tumor cells. Patients aged ≥18 years who have histologically confirmed urothelial carcinoma of the bladder and have not received systemic cytotoxic chemotherapy for their disease may be eligible for enrollment if other criteria are met. All eligible patients will receive treatment with celecoxib plus gemcitabine and neoadjuvant chemotherapy with cisplatin.

The primary outcome measures are the quantity and severity of adverse events, and the messenger RNA expression in tissues before and after chemotherapy. The secondary outcome measures include PFS and OS at 2 years. This study plans to enroll 15 patients at 2 locations in Houston, TX. For more information, contact Edward Yen, MD, at 713-798-3750, or Aihua Edward Yen, MD, at 713-798-3750 or ay044661@bcm.edu. The NLM Identifier is NCT02885974.

7 Pembrolizumab versus Placebo After First-Line Chemotherapy in Patients with Metastatic Urothelial Cancer

The purpose of this randomized, double-blind, parallel-assignment, phase 2 clinical trial is to compare the use of maintenance pembrolizumab with placebo in patients with metastatic bladder cancer who achieved stable disease with first-line chemotherapy. Patients aged ≥18 years with histologically or cytologically confirmed urothelial cancer of the bladder, urethra, ureter, or renal pelvis, and with an ECOG performance status score of ≤1 within the 14 days before trial registration may be eligible for enrollment if other criteria are met. Eligible patients will be given IV pembrolizumab or placebo.

The primary outcome measure is PFS at 6 months. The secondary outcome measures include the safety and tolerability of pembrolizumab (measured by the proportion of patients who have adverse events), OS, and the objective response rate. This study plans to enroll 200 patients at multiple locations across the United States. For more information, contact Matthew Galsky, MD, at 212-241-6756 or matthew.galsky@mssm.edu, or Dana Musapatika at 317-634-5842, ext 39 or dmusapatika@hoosiercancer.org. The NLM Identifier is NCT02500121.

8 Safety and Efficacy of Sirolimus plus Cisplatin and Gemcitabine for Patients with Bladder Cancer

The objective of this single-group, open-label, phase 1/2 clinical trial is to evaluate the side effects and best dose of sirolimus when given in combination with cisplatin and gemcitabine hydrochloride, as well as to assess how well this combination works in the treatment of patients with bladder cancer. Patients aged ≥18 years who have histologically or cytologically confirmed bladder cancer and an ECOG performance status score of ≤1 may be eligible for enrollment if other criteria are met. All eligible patients will receive treatment with oral sirolimus, IV cisplatin, and IV gemcitabine hydrochloride.

The primary outcome measures are the maximum tolerated dose of sirolimus (defined by the incidence of dose-limiting toxicity), and the proportion of patients who have a pathologic complete response. The secondary outcome measures are the DNA microenvironment damage–responsive proteins and transcripts via immunohistochemistry assay and polymerase chain reaction, and the incidence of adverse events. This study plans to enroll 45 patients at 2 locations in Seattle, WA. For more information, contact Robert B. Montgomery at 206-616-8289 or rbmontgo@uw.edu. The NLM Identifier is NCT01938573.

9 Effect of Tamoxifen Therapy in Patients with Low-/Intermediate-Risk Bladder Tumors

The objective of this open-label, single-group, phase 2 clinical trial is to evaluate the efficacy of tamoxifen therapy in patients with low-/intermediate-risk bladder tumors. Patients aged ≥21 years who have histologic evidence of urothelial bladder cancer, multifocal tumors with resectable lesions, and adequate hepatic and renal function may be eligible for enrollment if other criteria are met. All eligible patients will be given tamoxifen 20 mg daily for 12 weeks in accordance with a marker-lesion study design.

The primary outcome measure is the efficacy of using tamoxifen for the treatment of patients with low-/intermediate-risk bladder tumors, including assessment for the clinical response of the marker lesion. This study plans to enroll 19 patients at the Baylor College of Medicine, Houston, TX. For more information, contact Shameka Jones, CCRP, at 713-798-9989 or Shameka.Jones@bcm.edu. The NLM Identifier is NCT02197897.

10 Safety and Efficacy of CG0070 in Patients with High-Grade, Nonmuscle-Invasive Bladder Cancer

The objective of this open-label, single-group, phase 3 clinical trial is to evaluate the safety and efficacy of using CG0070, an oncolytic virus expression granulocyte macrophage colony-stimulating factor, for the treatment of patients with high-grade, nonmuscle-invasive bladder cancer who refused cystectomy, and in whom BCG therapy was unsuccessful. Patients aged ≥18 years who have pathologically confirmed high-grade, nonmuscle-invasive bladder cancer, and whose disease did not respond successfully to BCG induction therapy within a 6-month period—or who were successfully treated with BCG but subsequently had disease recurrence—may be eligible for enrollment if other criteria are met. All eligible patients will be treated with CG0070.

The primary outcome measure is the durable complete response proportion. The secondary outcome measures include cystectomy-free survival, PFS, and OS. This study plans to enroll 122 patients at multiple locations across the United States. For more information, contact Avantika Tahim, MS, at 714-884-3953 or avantika.tahim@coldgenesys.com, or Dominic Curran, MBChB, at 714-884-3953 or dominic.curran@coldgenesys.com. The NLM Identifier is NCT02365818.

11 Bacillus Calmette-Guérin plus ALT-803 for Patients with Nonmuscle-Invasive Bladder Cancer

The purpose of this multicenter, randomized, open-label, phase 1b/2 clinical trial is to evaluate the safety of combining BCG with ALT-803 in patients with nonmuscle-invasive bladder cancer. The maximum tolerated dose of ALT-803 and recommended dose of ALT-803 to combine with BCG in this patient population will also be assessed. Patients aged ≥18 years with histologically confirmed nonmuscle-invasive transitional-cell carcinoma of the bladder and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive BCG alone or in combination with ALT-803.

The primary outcome measures are the safety profile of the combination therapy, and determination of the maximum tolerated dose and recommended dose. The secondary outcome measures include OS, clinical benefit, and immune-cell assessment. This study plans to enroll 81 patients at multiple locations across the United States. For more information, contact Nazy Zomorodian, NP, at nzomorodian@mednet.ucla.edu, or Kaitlin Kosinski, MS, at 516-535-1900 or KKosinski@Winthrop.org. The NLM Identifier is NCT02138734.

12 Radiation Therapy and Concurrent Chemotherapy for Patients with Stage I Bladder Cancer

The objective of this open-label, single-group, phase 2 clinical trial is to evaluate the use of radiation therapy in tandem with chemotherapy for the treatment of patients with stage I bladder cancer. Patients aged 18 to 120 years who have pathologically confirmed bladder cancer within the 105 days before registration and no evidence of distant metastases may be eligible for enrollment if other criteria are met. All eligible patients will undergo a transurethral resection of the bladder tumor and receive concurrent radiation therapy plus chemotherapy.

The primary outcome measure is the rate of freedom from radical cystectomy at 3 years. The secondary outcome measures include disease-specific survival, OS, and the efficacy of the trial therapy in preventing local bladder tumor recurrence. This study plans to enroll 37 patients at multiple locations across the United States. For more information, contact the Clinical Trials Office at the Norris Cotton Cancer Center at 603-650-7609 or cancerhelp@dartmouth.edu. The NLM Identifier is NCT00981656.

13 Responses to 2 Induction Courses of Bacillus Calmette-Guérin in Patients with High-Risk Bladder Cancer

The objective of this open-label, single-group, phase 2 clinical trial is to evaluate whether using more treatment courses of BCG is better than therapy with just 1 course. Patients aged ≥18 years who have pathologically confirmed high-risk nonmuscle-invasive bladder cancer who are not currently receiving treatment for their condition or are scheduled to have radiation treatment may be eligible for enrollment if other criteria are met. All eligible patients will receive 2 induction courses of BCG, with a recovery period between the 2 therapy courses.

The primary outcome measure is the response rate at 1 year, determined via cystoscopy and cytology. The secondary outcome measure is the proportion of patients whose disease progresses to being muscle invasive. This study plans to enroll 75 patients at multiple locations in New Jersey and New York. For more information, contact Harry W. Herr, MD, at 646-422-4411, or Sherri M. Donat, MD, at 646-422-4398. The NLM Identifier is NCT02281383.

14 MK-3475 in Combination with Bacillus Calmette-Guérin for Patients with High-Risk Superficial Bladder Cancer

The purpose of this single-group, open-label, phase 1 clinical trial is to evaluate the safety and efficacy of using MK-3475 in combination with bladder-infused BCG therapy for the treatment of patients with high-risk superficial bladder cancer whose bladder tumor was removed. Patients aged ≥18 years with pathologically documented high-grade transitional-cell superficial bladder cancer or high-grade carcinoma in situ of the bladder at the time of initial resection for recurrent or persistent high-risk transitional-cell superficial bladder cancer, and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be given IV MK-3475 and intravesical BCG.

The primary outcome measure is the safety of the trial therapy, measured by the grade and quantity of adverse events. The secondary outcome measures are the complete response rate, and quality of life, measured using a questionnaire and the American Urological Association Symptoms Index. This study plans to enroll 15 patients at 2 locations in Springfield, IL. For more information, contact Shaheen Alanee, MD, MPH, at 217-545-8094 or salanee@siumed.edu, or Kathy Robinson, PhD, at 217-545-1946 or krobinson@siumed.edu. The NLM Identifier is NCT02324582.