A phase 3, randomized, comparator-controlled clinical trial to study the efficacy and safety of pembrolizumab (MK-3475) in combination with bacillus Calmette-Guerin (BCG) in participants with high-risk non-muscle invasive bladder cancer (HR NMIBC) that is persistent or recurrent following BCG induction (KEYNOTE-676). NCT03711032
An open label, randomized, phase III trial, evaluating efficacy of atezolizumab in addition to one year BCG (bacillus Calmette-Guerin) bladder instillation in BCG-naive patients with high-risk non-muscle invasive bladder cancer. NCT03799835
Balar AV et al. Atezolizumab (atezo) in first-line cisplatin-ineligible or platinum-treated locally advanced or metastatic urothelial cancer (mUC): Long-term efficacy from phase 2 study IMvigor210. ASCO 2018;Abstract 4523.
Balar AV et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: A single-arm, multicentre, phase 2 trial. Lancet 2017;389(10064):67-76. Abstract
Black, PC et al. Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer: SWOG S1605 (NCT #02844816). ASCO 2020;Abstract 5022.
Brahmer JR et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2018;36(17):1714-68. Abstract
Galsky MD et al. Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study. ASCO 2020;Abstract 5011.
Grande E et al. DUTRENEO trial: A randomized phase II trial of DUrvalumab and TREmelimumab versus chemotherapy as a NEOadjuvant approach to muscle-invasive urothelial bladder cancer (MIBC) patients (pts) prospectively selected by an interferon (INF)-gamma immune signature. ASCO 2020;Abstract 5012.
Grande E et al. IMvigor130: Efficacy and safety from a phase III study of atezolizumab (atezo) as monotherapy or combined with platinum-based chemotherapy (PBC) vs placebo + PBC in previously untreated locally advanced or metastatic urothelial carcinoma (mUC). ESMO 2019;Abstract LBA14_PR.
Gupta S et al. Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy. Genitourinary Cancers Symposium 2020;Abstract 439.
Hemdan T et al. 5-Year outcome of a randomized prospective study comparing bacillus Calmette-Guérin with epirubicin and interferon-α2b in patients with T1 bladder cancer. J Urol 2014;191(5):1244-9. Abstract
Hussain MHA et al. IMvigor010: Primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC). ASCO 2020;Abstract 5000.
Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract
Leow JJ et al. Adjuvant chemotherapy for invasive bladder cancer: A 2013 updated systematic review and meta-analysis of randomized trials. Eur Urol 2014;66(1):42-54. Abstract
Loriot Y et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N Engl J Med 2019;381(4):338-48. Abstract
Michot JM et al. Immune-related adverse events with immune checkpoint blockade: A comprehensive review. Eur J Cancer 2016;54:139-48. Abstract
Nechhi A et al. Pembrolizumab as neoadjuvant therapy before radical cystectomy in patients with muscle-invasive urothelial bladder carcinoma (PURE-01): An open-label, single-arm, phase II study. J Clin Oncol 2018;36(34):3353-60. Abstract
O’Donnell PH et al. Biomarker findings and mature clinical results from KEYNOTE-052: First-line pembrolizumab (pembro) in cisplatin-ineligible advanced urothelial cancer (UC). ASCO 2017;Abstract 4502.
Postow MA. Managing immune checkpoint-blocking antibody side effects. Am Soc Clin Oncol Educ Book 2015;76-83. Abstract
Powles T et al. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. ASCO 2020;Abstract LBA1.
Powles T et al. A phase II study investigating the safety and efficacy of neoadjuvant atezolizumab in muscle invasive bladder cancer (ABACUS). ASCO 2018;Abstract 4506.
Rosenberg JE et al. Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy. J Clin Oncol 2019;37(29):2592-600. Abstract
Vuky J et al. Updated efficacy and safety of KEYNOTE-052: A single-arm phase 2 study investigating first-line pembrolizumab (pembro) in cisplatin-ineligible advanced urothelial cancer (UC). ASCO 2018;Abstract 4524.
Xu W et al. Neoadjuvant chemotherapy in clinically node positive urothelial bladder cancer. American Urological Association 2020;Abstract MP61-15.