The following clinical trials represent a selection of key studies currently recruiting patients with bladder 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.

The purpose of this open-label, multicenter, randomized phase 3 study is to evaluate the efficacy and safety of TAR-200, a novel intravesical drug delivery system, alone or in combination with cetrelimab (JNJ-63723283) versus intravesical Bacillus Calmette-Guérin (BCG) in patients with BCG-naïve, high-risk, nonmuscle-invasive bladder cancer (NMIBC). Patients aged ≥18 years with histologically confirmed initial diagnosis by local pathology; who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; who have not received previous intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization; and who have resolved grade <2 adverse events (AEs) associated with any previous surgery and/or intravesical therapy per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 may be eligible if other criteria are met. Eligible participants will be randomized to receive either TAR-200 alone or with cetrelimab every 3 weeks; or intravesical BCG once every week for 6 weeks for induction therapy, followed by once every week for 3 weeks at weeks 12, 24, 48, 72, and 96 as maintenance therapy.

The primary outcome measure is event-free survival (EFS) from time of randomization to the time of first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. Secondary outcome measures include overall complete response (CR) rate and duration of CR; recurrence-free survival (RFS); time to disease progression; overall survival (OS); number of participants with AEs; and change in baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-NMIBC 24 scores. The study plans to enroll approximately 1050 participants throughout the United States and worldwide. For more information, contact Janssen Research & Development at 1-844-434-4210 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05714202.

The purpose of this randomized phase 3 study is to compare the effect of adding cabozantinib (Cabometyx) to avelumab (Bavencio) versus avelumab alone as maintenance therapy after first-line platinum-based chemotherapy in the treatment of metastatic urothelial cancer. Patients aged ≥18 years with histologically or cytologically confirmed diagnosis of advanced or metastatic urothelial cancer; who have received 4 to 6 cycles of previous first-line platinum-based chemotherapy, but no more than 1 line of previous chemotherapy, and who have received the last dose no less than 3 weeks and no more than 10 weeks prior to randomization; and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible participnts will be randomized to receive either avelumab intravenous (IV) on days 1 and 15 of each 28-day cycle for 24 months, or avelumab IV on days 1 and 15 and cabozantinib orally on days 1-28 of each 28-day cycle for 24 months.

The primary outcome measure is OS from time of randomization until death due to any cause, assessed up to 5 years. Secondary outcome measures include progression-free survival (PFS); tumor response as per immune-modified RECIST; and the incidence of AEs per NCI CTCAE 5.0. The study plans to enroll approximately 654 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly. The NLM identifier is NCT05092958.

The purpose of this randomized, open-label, multicenter, global, phase 3 study is to determine the efficacy and safety of combining durvalumab (Imfinzi) plus standard-of-care (SOC) chemotherapy with or without tremelimumab (Imjudo) versus SOC chemotherapy alone as first-line treatment in patients with unresectable, locally advanced or metastatic transitional cell urothelial carcinoma. Patients aged ≥18 years with histologically or cytologically documented disease who have not received previous first-line chemotherapy; who have at least 1 lesion not previously irradiated that qualifies as RECIST version 1.1 target lesion at baseline; and who have a World Health Organization/ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible participants will be randomized to receive either durvalumab IV every 3 weeks in concurrence with SOC chemotherapy every 3 weeks for 6 cycles, followed by durvalumab monotherapy every 4 weeks; durvalumab and tremelimumab IV every 3 weeks for 4 cycles in concurrence with SOC chemotherapy every 3 weeks for 6 cycles, followed by durvalumab monotherapy every 4 weeks; or SOC chemotherapy regimens every 3 weeks for 6 cycles.

The primary outcome measure is OS from date of randomization until death due to any cause for approximately 5 years. Secondary outcome measures include OS at 24 months; PFS; objective response rate (ORR); duration of response (DOR); and disease control rate (DCR). The study plans to enroll approximately 1292 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03682068.

The purpose of this randomized, open-label, phase 3 study is to assess the antitumor effect and safety of perioperative enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) and radical cystectomy plus pelvic lymph node dissection compared with SOC neoadjuvant gemcitabine and cisplatin in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC). Patients aged ≥18 years with histologically confirmed diagnosis of urothelial carcinoma/MIBC; who have clinically NMIBC determined by imaging; who are eligible for radical cystectomy plus pelvic lymph node dissection; and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible participants will be randomized to receive either 4 cycles of enfortumab vedotin 1.25 mg/kg IV plus pembrolizumab 200 mg IV preoperatively, followed by radical cystectomy plus pelvic lymph node dissection, followed by 5 cycles of enfortumab vedotin IV plus pembrolizumab IV postoperatively; or SOC chemotherapy preoperatively followed by radical cystectomy plus pelvic lymph node dissection.

The primary outcome measure is EFS from time of randomization to first occurrence of disease progression or death due to any cause, whichever occurs first. Secondary outcome measures include pathologic complete response, OS, pathologic downstaging rate, number of participants who have an AE and the number of participants who discontinued study treatment due to an AE, disease-free survival (DFS), time to deterioration, and change from baseline in EORTC QLQ-C30. The study plans to enroll approximately 784 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme 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 NCT04700124.

The purpose of this open-label, randomized, controlled phase 3 study is to evaluate the efficacy of disitamab vedotin (RC48) in combination with pembrolizumab (Keytruda) versus platinum-containing chemotherapy in the treatment of previously untreated, locally advanced or metastatic, urothelial carcinoma that expresses HER2. Patients aged ≥18 years with histopathological confirmation of locally advanced, unresectable, or metastatic urothelial carcinoma; who have not received previous systemic therapy; who are eligible to receive cisplatin- or carboplatin-containing chemotherapy; who have HER2 expression of 1+ or greater on immunohistochemistry; and who have an ECOG performance status of 0, 1, or 2 within 7 days prior to randomization may be eligible if other criteria are met. Eligible participants will be randomized to receive either disitamab vedotin IV every 2 weeks plus pembrolizumab 400 mg IV every 6 weeks; or SOC chemotherapy of gemcitabine 1000 mg/m² IV plus cisplatin 70 mg/m² IV or carboplatin IV.

The primary outcome measures include PFS per RECIST version 1.1 by blinded independent central review, and OS. Secondary outcome measures include ORR, DOR, DCR, PFS, number of participants with AEs and treatment discontinuation rate due to AEs, and time to deterioration and change in baseline in EORTC QLQ-C30. The study plans to enroll approximately 700 participants throughout the United States and worldwide. For more information, contact Seagen Trial Information Support at 1-866-333-7436 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05911295.

The purpose of this randomized, comparator-controlled, phase 3 study is to assess the efficacy and safety of pembrolizumab (Keytruda) in combination with BCG in the treatment of patients with high-risk NMIBC that is either persistent or recurrent following BCG induction or that is BCG-naïve. Patients aged ≥18 years with locally and blinded independent central review–confirmed histological diagnosis of high-risk NMIBC; who have had cystoscopy/transurethral resection of bladder tumor to remove all resectable disease; and who have an ECOG performance status of 0, 1, or 2 may be eligible if other criteria are met. Eligible participants will be randomized to receive either intravesical BCG alone or with pembrolizumab IV.

The primary outcome measures include CR rate and EFS. Secondary outcome measures include EFS, RFS, OS, disease-specific survival, DOR, percentage of participants with AEs and the percentage of participants who discontinue study drug due to AE, change in baseline in EORTC QLQ-C30, and time to deterioration. The study plans to enroll approximately 1405 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme 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 NCT03711032.

The purpose of this randomized, open-label, multicenter, phase 3 study is to determine the efficacy and safety of durvalumab (Imfinzi) and enfortumab vedotin (Padcev) with or without tremelimumab (Imjudo) compared with current SOC in patients who are cisplatin-ineligible or who refuse cisplatin undergoing radical cystectomy for MIBC. Patients aged ≥18 years with histologically or cytologically documented MIBC, with transitional cell and mixed transitional/nontransitional cell histologies; who have not received previous systemic chemotherapy or immunotherapy for the treatment of MIBC; who have been determined to be cisplatin-ineligible or have documented refusal of cisplatin-based chemotherapy; and who have an ECOG performance status of 0, 1, or 2 may be eligible if other criteria are met. Eligible participants will be randomized to receive either durvalumab plus tremelimumab plus enfortumab vedotin; durvalumab plus enfortumab vedotin; or radical cystectomy with SOC treatment.

The primary outcome measures include safety and tolerability as evaluated by AEs throughout the study and changes in ECOG performance status. Secondary outcome measures include pathologic complete response rates, EFs, OS, DFS, pathologic downstaging, disease-specific survival, changes in baseline for EORTC QLQ-C30, metastasis-free survival (MFS), time to maximum serum concentration of durvalumab and tremelimumab, and immunogenicity of durvalumab. The study plans to enroll approximately 830 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04960709.

The purpose of this randomized, double-blind, placebo-controlled phase 3 study is to assess the efficacy and safety of pembrolizumab (Keytruda) plus chemoradiotherapy (CRT) versus CRT alone in patients with MIBC. Patients aged ≥18 years with a histologically confirmed disease with clinically nonmetastatic bladder cancer; who are eligible to receive CRT; and who have an ECOG performance status of 0, 1, or 2 may be eligible if other criteria are met. Eligible participants will be randomized to receive either pembrolizumab 400 mg IV once every 6 weeks plus 1 of 3 chemotherapy regimens and 1 of 3 radiotherapy regimens chosen by investigator, or CRT alone.

The primary outcome measure is bladder-intact EFS from time of randomization up to 71 months. Secondary outcome measures include OS, MFS, number of participants with an AE and the number of those who stopped study due to an AE, time to deterioration, and time to cystectomy. The study plans to enroll approximately 636 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme 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 NCT04241185.

The purpose of this multicenter, randomized, phase 3 study is to evaluate the efficacy of TAR-200 plus cetrelimab (JNJ-63723283) versus concurrent CRT in patients with MIBC who are not receiving radical cystectomy. Patients aged ≥18 years who are ineligible or have elected not to receive radical cystectomy; whose AEs from previous surgeries and/or intravesical therapy must have resolved to grade <2 CTCAE version 5.0 prior to randomization; and who have an ECOG performance status of 0, 1, or 2 may be eligible if other criteria are met. Eligible participants will be randomized to receive intravesical TAR-200 and cetrelimab IV, or cisplatin or gemcitabine and SOC radiation therapy.

The primary outcome measure is time from randomization to first bladder-intact EFS event. Secondary outcome measures include MFS, OS, ORR, number of participants with AEs, number of AEs by severity, and number of participants with clinical laboratory abnormalities. The study plans to enroll approximately 550 participants throughout the United States and worldwide. For more information, contact Janssen Research & Development at 1-844-434-4210 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04658862.

The purpose of this randomized, double-blind, multicenter, global, phase 3 study is to evaluate the efficacy and safety of adjuvant atezolizumab (Tecentriq) compared with placebo in patients with high-risk MIBC whose disease is circulating tumor (ct)DNA-positive following cystectomy. Patients aged ≥18 years with histologically confirmed disease; who have absence of residual disease and absence of metastasis as confirmed by imaging no more than 28 days prior to randomization; who have achieved a full recovery from cystectomy and enrollment within 24 weeks following cystectomy; and who have an ECOG performance status of ≤2 may be eligible if other criteria are met. Eligible participants will be randomized to receive either atezolizumab 1680 mg IV every 4 weeks on day 1 of each 28-day cycle for 12 cycles or up to 1 year, or placebo.

The primary outcome measure is investigator-assessed DFS in patients who are ctDNA-positive within 24 weeks of cystectomy. Secondary outcome measures include OS, DFS, MFS, time to deterioration in EORTC QLQ-C30, percentage of participants with AEs, serum concentration of atezolizumab, and incidence and prevalence of antidrug antibodies to atezolizumab. The study plans to enroll approximately 520 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or This email address is being protected from spambots. You need JavaScript enabled to view it., and reference study ID number BO42843. The NLM identifier is NCT04660344.