Elizabeth R Plimack, MD, MS
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
A phase 3, randomized, double-blind, placebo-controlled clinical trial to study the efficacy and safety of pembrolizumab (MK-3475) in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC) (KEYNOTE-992). NCT04241185
A phase 3, randomized, study of neoadjuvant chemotherapy alone versus neoadjuvant chemotherapy plus nivolumab or nivolumab and BMS-986205, followed by continued post- surgery therapy with nivolumab or nivolumab and BMS-986205 in participants with muscle- invasive bladder cancer. NCT03661320
A phase III, randomized, open-label, multi-center, global study to determine the efficacy and safety of durvalumab in combination with gemcitabine+cisplatin for neoadjuvant treatment followed by durvalumab alone for adjuvant treatment in patients with muscle-invasive bladder cancer. NCT03732677
A phase III randomized, open-label, multi-center, global study of durvalumab and bacillus Calmette-Guerin (BCG) administered as combination therapy versus BCG alone in high-risk, BCG naïve non-muscle invasive bladder cancer patients. NCT03528694
A phase 3 randomized study of cystectomy plus perioperative pembrolizumab versus cystectomy alone in cisplatin-ineligible participants with muscle-invasive bladder cancer (KEYNOTE-905). NCT03924895
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
De Wit R. Health-related quality of life (HRQoL) and updated follow-up from KEYNOTE-057: Phase II study of pembrolizumab (pembro) for patients (pts) with high-risk (HR) non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG). ESMO 2019;Abstract 916P.
Grossman HB et al Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med 2003;349(9):859-66. Abstract
Necchi A et al. Multiparametric magnetic resonance imaging as a noninvasive assessment of tumor response to neoadjuvant pembrolizumab in muscle-invasive bladder cancer: Preliminary findings from the PURE-01 study. Eur Urol 2019;[Epub ahead of print]. Abstract
Phase III randomized trial of concurrent chemoradiotherapy with or without atezolizumab in localized muscle invasive bladder cancer (study SWOG/NRG 1806). NCT03775265
Powles T et al. Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial. Nat Med 2019;25(11):1706–14. Abstract
Jonathan E Rosenberg, MD
A phase 3, multicenter, multinational, randomized, open-label, parallel-arm study of avelumab (MSB0010718C) plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after completion of first-line platinum-containing chemotherapy. NCT02603432
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
De Santis M et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol 2012;30(2):191-9. Abstract
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 LBA_14PR.
O’Donnell PH et al. KEYNOTE-052: Phase 2 study evaluating first-line pembrolizumab (pembro) in cisplatin-ineligible advanced urothelial cancer (UC)— Updated response and survival results. ASCO 2019;Abstract 4546.
Peter H O’Donnell, MD
A phase 1/2, open-label, multicenter study to investigate the safety and preliminary efficacy of NKTR-214 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors. NCT03138889
A phase 2, single-arm study of bempegaldesleukin (NKTR-214) in combination with nivolumab in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients. NCT03785925
Bellmunt J et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med 2017;376(11):1015-26. Abstract
Boutros C et al. Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies alone and in combination. Nat Rev Clin Oncol 2016;13(8):473-86. Abstract
Charych D. Modeling the receptor pharmacology, pharmacokinetics, and pharmacodynamics of NKTR-214, a kinetically-controlled interleukin-2 (IL2) receptor agonist for cancer immunotherapy. PLoS One 2017;12(7):e0179431. Abstract
Nadal R, Bellmunt J. Management of metastatic bladder cancer. Cancer Treat Rev 2019;76:10-21. Abstract
Patel MR et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): Pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol 2018;19(1):51-64. Abstract
Powles T et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase ½ open-label study. JAMA Oncol 2017;3(9):e172411. Abstract
Sharma P et al. Nivolumab alone and with ipilimumab in previously treated metastatic urothelial carcinoma: CheckMate 032 nivolumab 1 mg/kg plus ipilimumab 3 mg/kg expansion cohort results. J Clin Oncol 2019;37(19):1608-16. Abstract
Sharma P et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): A multicentre, single-arm, phase 2 trial. Lancet Oncol 2017;18(3):312-22. Abstract
Daniel P Petrylak, MD
An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer. NCT04223856
An open-label, randomized phase 3 study to evaluate enfortumab vedotin vs chemotherapy in subjects with previously treated locally advanced or metastatic urothelial cancer (EV-301). NCT03474107
Hoimes CJ et al. EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. ESMO 2019;Abstract 901O.
Petrylak DP et al. EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors. ASCO 2019;Abstract LBA4505.
Petrylak DP et al. A phase I study of enfortumab vedotin: Updated analysis of patients with metastatic urothelial cancer. ASCO 2017;Abstract 106.
Rosenberg JE et al. Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Gastrointestinal Cancers Symposium 2020;Abstract 441.
Tagawa ST et al. Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study. Gastrointestinal Cancers Symposium 2019;Abstract 354.
Guru Sonpavde, MD
Grünewald S et al. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer 2019;145(5):1346-57. Abstract
Gust KM et al. Fibroblast growth factor receptor 3 is a rational therapeutic target in bladder cancer. Mol Cancer Ther 2013;12(7):1245-54. Abstract
Loriot Y et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N Engl J Med 2019; 381(4):338-48. Abstract
Loriot Y et al. Erdafitinib (ERDA; JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRa): Phase 2 continuous versus intermittent dosing. Gastrointestinal Cancers Symposium 2018; Abstract 411
Nassar AH et al. Enrichment of FGFR3-TACC3 Fusions in patients with bladder cancer who are young, Asian, or have never smoked. JCO Precis Oncol 2018;2:1-11. Abstract
Perera TPS et al. Discovery and pharmacological characterization of JNJ-42746493 (erdafitinib), a functionlally selective small-molecule FGFR family inhibitor. Mol Cancer Ther 2017;16(6):1010-20. Abstract
Robertson AG et al. Comprehensive molecular characterization of muscle-invasive bladder cancer. Cell 2018;171(3):540-56.e25. Abstract
Sfakianos JP et al. Genomic characterization of upper tract urothelial carcinoma. Eur Urol 2015;68(6):970-7. Abstract
Siefker-Radtke A et al. Efficacy of programmed death 1 (PD-1) and programmed death 1 ligand (PD-L1) inhibitors in patients with FGFR mutations and gene fusions: Results from a data analysis of an ongoing phase 2 study of erdafitinib (JNJ-42756493) in patients (pts) with advanced urothelial cancer (UC). Gastrointestinal Cancers Symposium 2018;Abstract 450.
Soria JC et al. Safety and activity of the pan–fibroblast growth factor receptor (FGFR) inhibitor erdafitinib in phase 1 study patients with advanced urothelial carcinoma. ESMO 2016;Abstract 781PD.
Tabernero J et al Phase I dose-escalation study of JNJ-42756493, an oral pan-fibroblast growth factor receptor inhibitor, in patients with advanced solid tumors. J Clin Oncol 2015;33(30):3401-8. Abstract
Wang L et al. Fibroblast growth factor receptor 3 alterations and response to PD-1/PD-L1 blockade in patients with metastatic urothelial cancer. Eur Urol 2019;76(5):599-603. Abstract