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Select Ongoing Trials Currently Enrolling Patients with Urothelial Carcinoma

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


1 Pembrolizumab plus Lenvatinib versus Pembrolizumab Alone in Urothelial Carcinoma

The purpose of this randomized, double-blind, phase 3 clinical trial is to compare the efficacy and safety of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) versus pembrolizumab alone for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma whose tumors express programmed cell death-ligand 1 (PD-L1) and who are ineligible to receive cisplatin or any platinum-containing chemotherapy. Patients aged ≥18 years with a histologically or cytologically confirmed diagnosis of advanced or unresectable or metastatic urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, who have ≥1 measurable target lesions per RECIST version 1.1 criteria, who have not received any previous systemic chemotherapy, and who have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 within 7 days of randomization may be eligible if other criteria are met. Eligible patients will be randomized to receive either pembrolizumab 200 mg intravenously (IV) on day 1 of each 21-day cycle for up to 35 cycles plus either lenvatinib 20 mg orally (PO) once daily or placebo until disease progression or discontinuation.

The primary outcome measures include progression-free survival (PFS) per RECIST version 1.1, defined as time from randomization to first documented progressive disease or death from any cause, whichever comes first, and overall survival (OS) from time of randomization to the date of death from any cause. Secondary outcome measures include objective response rate (ORR), duration of response (DOR), and disease control rate (DCR) as per RECIST version 1.1, time to deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), and the number of patients who have adverse events (AEs) or who discontinue treatment due to AEs. The study plans to enroll 694 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme Corp at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03898180.


2 Oral Infigratinib as Adjuvant Therapy in Invasive Urothelial Carcinoma with FGFR3 Genetic Alterations

The purpose of this randomized, double-blind, multicenter, placebo-controlled, phase 3 clinical trial is to evaluate the efficacy of infigratinib (BGJ398), an oral targeted fibroblast growth factor receptor (FGFR) 1-3 inhibitor, as adjuvant treatment following surgery in patients with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations whose disease is considered high-risk for recurrence with surgery alone. Patients aged ≥18 years with histologically or cytologically confirmed invasive urothelial carcinoma with susceptible FGFR3 alterations within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy, who have an ECOG performance status of ≤2, have no evidence of metastatic disease, and whose disease pathologic stage at surgical resection is American Joint Committee on Cancer stage ≥ypT2 and/or yN+ may be eligible if other criteria are met. Eligible patients will be randomized to receive infigratinib 125 mg PO or placebo once daily for the first 3 weeks (21 days) of each 28-day cycle for up to a maximum of 52 weeks.

The primary outcome measure is disease-free survival (DFS) from randomization until 1 year after the end of treatment. Secondary outcome measures include comparison of DFS from randomization until 5 years after the end of treatment, metastasis-free survival, OS, and the number of patients with AEs and serious AEs. The study plans to enroll 218 participants throughout the United States and worldwide. For more information, contact QED Therapeutics at 1-877-280-5655 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04197986.


3 Eribulin Mesylate with or without Gemcitabine versus Chemotherapy in Metastatic Urothelial Carcinoma

The purpose of this randomized, phase 3 clinical trial is to assess the efficacy of eribulin mesylate (Halaven) alone, or in combination with gemcitabine hydrochloride (Gemzar), versus standard-of-care chemotherapy in the treatment of patients with metastatic urothelial carcinoma who are refractory to, or ineligible for, anti–PD-1/PD-L1 therapy. Patients aged ≥18 years with predominant histologically and cytologically proven metastatic urothelial carcinoma whose disease progressed following previous therapy with either a platinum-based chemotherapy regimen, PD-1/PD-L1 immunotherapy, or an antibody–drug conjugate, who have a Zubrod performance status of 0-2, and who have adequate kidney and hepatic function may be eligible if other criteria are met. Eligible patients will be randomized to receive standard-of-care chemotherapy (docetaxel IV on day 1 every 21 days; gemcitabine IV on days 1, 8, and 15 every 28 days; or paclitaxel IV on days 1, 8, and 15 every 21 days), eribulin mesylate IV on days 1 and 8 every 21 days, or eribulin mesylate IV plus gemcitabine IV on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.

The primary outcome measure is OS from date of registration to date of death due to any cause, assessed up to 3 years. Secondary outcome measures include PFS from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, ORR, DOR, and DCR for up to 3 years. This study plans to enroll 465 participants throughout the United States. For more information, contact the sites directly. The NLM identifier is NCT04579224.


4 Sacituzumab Govitecan versus Paclitaxel, Docetaxel, or Vinflunine in Locally Advanced or Metastatic Unresectable Urothelial Carcinoma

The purpose of this randomized, global, multicenter, open-label, phase 3 study is to assess the efficacy and safety of sacituzumab govitecan (Trodelvy) alone versus physician’s choice of paclitaxel, docetaxel, or vinflunine in patients with metastatic or locally advanced unresectable urothelial carcinoma whose disease progressed after previous therapy with a platinum-based regimen and anti–PD-1/PD-L1 therapy. Patients aged ≥18 years with histologically documented metastatic or locally advanced unresectable disease with an ECOG performance status of 0 or 1 and whose disease progressed on or recurred following platinum-containing treatment and anti–PD-1/PD-L1 therapy may be eligible if other criteria are met. Eligible patients will be randomized to receive sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of 21-day cycles, or physician’s choice of paclitaxel 175 mg/m2, docetaxel 75 mg/m2, or vinflunine 320 mg/m2 IV on day 1 of 21-day cycles.

The primary outcome measure is OS from time of randomization to date of death, regardless of cause, until study completion. Secondary outcome measures include PFS, ORR, clinical benefit rate, and DOR per RECIST version 1.1 criteria; the rate of AEs, serious AEs, and laboratory changes; QLQ-C30 score; and 5-level EQ-5D until study completion. The study plans to enroll 600 participants throughout the United States and worldwide. For more information, contact the Gilead Clinical Study Information Center at 1-833-445-3230, or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04527991.


5 UGN-102 with or without TURBT in Low-Grade, Intermediate-Risk, Non–muscle-Invasive Urothelial Carcinoma

The purpose of this randomized, controlled, open-label, phase 3 clinical trial is to assess the long-term efficacy, durability, and safety of UGN-102, an intravesical mitomycin and sterile hydrogel used to reconstitute mitomycin before instillation, with or without transurethral resection of bladder tumor (TURBT) versus TURBT alone in the treatment of patients with low-grade, intermediate-risk, non–muscle-invasive urothelial carcinoma. Patients aged ≥18 years with newly diagnosed or historic low-grade disease at intermediate risk for progression who have adequate organ and bone marrow function may be eligible if other criteria are met. Eligible patients will be randomized to receive UGN-102 75-mg intravesical instillations on day 1 for 6 weeks plus TURBT or TURBT alone on day 1, with repeat TURBT if participants in either arm have a noncomplete response at the 3-month assessment.

The primary outcome measure is DFS, defined as time from randomization to earliest date of disease recurrence or death due to any cause in patients with complete response at 3-month assessment, or the time from the repeat TURBT to earliest date of disease recurrence or death due to any cause in patients with noncomplete response at 3-month assessment. Secondary outcome measures include time to recurrence, complete response rate, DOR, incidence of TURBT, changes from baseline in health-related quality of life as per EORTC Non-Muscle-Invasive Bladder Cancer 24, and the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results. The study plans to enroll 632 participants throughout the United States and worldwide. For more information, contact John Saviski at 1-610-247-5164 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Nimrod Gabai at 1-646-793-3606 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04688931.


6 Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle-Invasive Urothelial Carcinoma

The purpose of this randomized phase 3 clinical trial is to assess the efficacy of concurrent chemoradiotherapy with or without atezolizumab (Tecentriq) in the treatment of patients with localized muscle-invasive urothelial carcinoma. Patients aged ≥18 years with histologically proven T2-T4a N0M0 urothelial carcinoma of the bladder within 120 days prior to randomization and no intervening treatment between histologic proof and randomization, who must undergo TURBT and radiologic staging within 70 days before randomization, have a Zubrod performance status of ≤2, and have adequate renal function may be eligible if other criteria are met. Eligible patients will be randomized to receive radiotherapy 5 days a week for up to 7 weeks plus chemotherapy based on physician’s choice with or without the addition of atezolizumab IV on day 1 of chemotherapy.

The primary outcome measure is bladder intact event-free survival from the date of randomization to the first documentation of event, assessed up to 5 years. Secondary outcome measures include OS, modified bladder intact event-free survival, biopsy response, PFS, complete response duration, cancer-specific survival, and treatment interactions. The study plans to enroll 475 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly. The NLM identifier is NCT03775265.


7 Pembrolizumab as Adjuvant Therapy for Muscle-Invasive and Locally Advanced Urothelial Carcinoma

The purpose of this randomized, phase 3 clinical trial is to assess the efficacy of pembrolizumab in the adjuvant setting for the treatment of patients with muscle-invasive and locally advanced urothelial carcinoma. Patients aged ≥18 years with an ECOG performance status of ≤2 and no evidence of residual cancer or metastasis after surgery, who have no active autoimmune disease or history of autoimmune disease that might recur and affect vital organ function or require immune suppressive treatment, and who have not received previous PD-1/PD-L1 therapy may be eligible if other criteria are met. Eligible patients will be randomized to pembrolizumab IV on day 1 every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity or observation.

The primary outcome measures are OS from randomization to the date of death from any cause and DFS from randomization to first metastatic recurrence, or death, whichever occurs first up to 5 years. Secondary outcome measures are OS and DFS in patients with PD-L1–positive and PD-L1–negative disease. The study plans to enroll 739 participants throughout the United States and worldwide. For more information, contact the recruiting site directly. The NLM identifier is NCT03244384.

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