Metastatic Urothelial - ClinicalTrials.gov

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This Phase II, single-arm study is designed to determine the effects of atezolizumab therapy in patients with locally advanced or metastatic urothelial bladder cancer. Participants in Cohort 1 will be treated until disease progression is identified, according to the Response Evaluation Criteria in Solid Tumors Version 1. 1 or unmanageable toxicity. Participants in Cohort 2 will continue to receive medical assistance until they become unmanageable or unmanageable toxicity.

Source link: https://clinicaltrials.gov/ct2/show/NCT02951767

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Participants who have progressed during or after a prior platinum-based chemotherapy treatment program will be included in Cohort 2: participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in Cohort 1 will be treated until disease progression, according to the Response Evaluation Criteria of Solid Tumors Version 1. 1 or unmanageable toxicity. Participants in Cohort 2 will continue to be treated until they lose clinical value or unmanageable toxicity.

Source link: https://clinicaltrials.gov/ct2/show/NCT02108652

Phase II Randomized Trial of Atezolizumab Versus Atezolizumab and Radiation Therapy for Platinum Ineligible/Refractory Metastatic Urothelial Cancer (ART)

To a single site, compare the overall response rates of patients with advanced urothelial carcinoma treated with immunotherapy alone and immunotherapy plus radiotherapy to a single site. Patient Reported Outcome - CTCAE's Common Terminology Criteria for Adverse Events and Patient Reported Outcome To investigate adverse events related to patients treated with immunotherapy and immunotherapy plus radiotherapy, use the Common Terminology Criteria for Adverse Events and Patient Reported Outcome. Patient-reported exhaustation as measured by the Patient Reported Outcome Measurement Information System - Fatigue 8a from baseline to 24 months between patients treated with immunotherapy alone and immunotherapy plus radiotherapy combined in a single location to a single site. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Core 30) rated health-related quality of life from baseline to 24 months between patients treated with immunotherapy alone and immunotherapy plus radiotherapy to a single site in order to compare health-related quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life -Core 30 from baseline to 24 months between patients treated with immunotherapy alone and immunotherapy plus radiotherapy plus radiotherapy to a single location. Compare urinary symptoms as measured by the EORTC QLQ-BLM30 from baseline to 24 months between patients treated with immunotherapy alone and immunotherapy plus radiotherapy to a single location, to a single location. To a single location, the V. To compare health services and quality-adjusted survival among patients treated with immunotherapy alone and immunotherapy plus radiotherapy is compared. Patients treated with immunotherapy alone and immunotherapy plus radiotherapy to a single site are compared to other scale scores on the EORTC QLQ-BLM30 and EORTC QLQ-BLM30 at 45 days, and at 6, 12, and 24 months between patients treated with immunotherapy alone and immunetherapy plus radiotherapy to a single site in a single location. Patients in Arm B: Patients are in Arm A: Patients receive atezolizumab as a result of Arm B.

Source link: https://clinicaltrials.gov/ct2/show/NCT04936230

A Phase I Study of Gemcitabine, Carboplatin and Lenalidomide (GCL) for Treatment of Patients With Advanced/Metastatic Urothelial Carcinoma (UC) and Other Solid Tumors

BIOKGROUND: Gemcitabine plus carboplatin is a well-known first-line therapy for patients with cisplatin chemotherapy of metastatic urothelial carcinoma or other solid tumor malignancies. Both non-clinical and clinical evidence support targeting the immune system in urothelial carcinoma and other solid tumors. Patients with solid tumors can be safely treated with cytotoxic therapy, and non-clinical studies have shown potential synergy with gemcitabine. Primary OBJECTIVES - To establish the dose-limiting toxicity and maximum tolerated dose of lenalidomide, which can be safely mixed with gemcitabine and carboplatin in patients with advanced/metastatic UC and other solid tumors that are unfit for cisplatin. In the MTD's expansion cohort of patients with bladder cancer treated at the MTD, the MTD determines the effects of therapy on a set of four laboratory variables. This is a single-institution phase I study of gemcitabine and carboplatin plus increasing doses of lenalidomide in patients with advanced/metastatic UC and other solid tumors that are ineligible for cisplatin therapy. An expansion cohort at the MTD for an additional 15 patients with bladder cancer will be included in order to see if there are any differences between pre-treatment and post-treatment levels of the following measurements: Treg, sIL-2R, VEGF, and CTC. A maximum of 24 patients with maximum 3+3 design with four dose levels per cohort, a maximum of 48 patients, may need to be evaluated to determine the dose limiting toxicities and maximum tolerated dose of lenalidomide in this combination therapy.

Source link: https://clinicaltrials.gov/ct2/show/NCT01352962

A Phase 1 Study of Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors

In patients with genitourinary tumors, determine the dose limiting toxicity and recommended phase II dose of cabozantinib s-malate and nivolumab and separately the combination of cabozantinib, nivolumab, and ipilimumab. Patients with urothelial carcinoma treated with checkpoint inhibition therapy in the second line or above setting were previously treated with checkpoint inhibition therapy in the second line or beyond setting, according to Cabo-nivo. Patients with urothelial carcinoma who were previously treated with checkpoint inhibition therapy in the second line or beyond setting were treated with checkpoint inhibition therapy in the second line or beyond setting. Patients receive cabozantinib s-malate orally on days 1-28 and nivolumab intravenously over 30 minutes on days 1 and 15. If post-cycle 21 patients have disease progression or unacceptable toxicity, patients can receive cabozantinib s-malate PO, nivolumab IV, and ipilimumab IV at the part II RP2D for four cycles, as well as ipilimumab IV and ipilimab IV every 2 weeks or four weeks after progression. Patients are treated with cabozantinib s-malate PO QD on day 1-21, nivolumab IV over 30 minutes on day 1 by the end of the day, and ipilimumab IV over 90 minutes on day 2 on day 1; patients are given cabozantinib s-malate PO QD on days 1-21, nivolumab IV over 90 minutes. Patients with ipilimumab's completion of four cycles are still receiving cabozantinib s-malate PO QD on days 1 and 15. Patients with diabetes medutab IV, nivolumab IV, and ipilimumab IV can be treated with cabozantinib s-malate PO, nivolumab IV, and ipilimumab IV every four cycles, with a post-cycle 21 if post-cycle 21 in the absence of disease progression or unacceptable toxicity, may be given if post-cycle 21.

Source link: https://clinicaltrials.gov/ct2/show/NCT02496208

A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

Enfortumab vedotin in patients with histologically diagnosed malignant solid tumors that are resistant or have recurred in Part A will be evaluated. In three separate expansion cohorts, 1 Urothelial cancer patients with renal insufficiency identified as a Creatinine Clearance 15 ml/min and 30 ml/min, 2 subjects with Metastatic Non Small Cell Lung Cancer NSCLC, and 3 subjects with Metastatic Ovarian Cancer will assess enfortumab vedotin. Part A of the renal insufficiency cohort will be launched at starting dose and escalated using a 3 + 3 dose escalation scheme. With the exception of the renal insufficiency cohort, enrollment in Part B will take place at the planned phase 2 dose RP2D established in Part A. Part C of the metastatic setting would determine enfortumab vedotin at the RP2D determined from Part A in patients who have been previously treated with immune checkpoint inhibitors CPI in the metastatic setting.

Source link: https://clinicaltrials.gov/ct2/show/NCT02091999

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

Enfortumab vedotin has been approved by the Japan Prime Minister for the treatment of advanced urothelial cancer. In patients with previously untreated locally advanced or metastatic urothelial cancer, this research is being conducted to determine the combination of enfortumab vedotin + pemophytin + platinum-containing chemotherapy. If research discontinuation is first, either Cisplatin or carboplatin plus gemcitabine can be administered for a maximum of 6 cycles or a protocol-defined reason for study cancellation occurs, whichever comes first.

Source link: https://clinicaltrials.gov/ct2/show/NCT04223856

Phase II, Multicenter, Non-randomized, Single-arm, Open-label Trial of Atezolizumab in Combination of Split-doses of Gemcitabine Plus Cisplatin in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Split cisplatin and atezolizumab are a cost-effective therapy that may have improved outcomes than carboplatin/based combinations. With cisplatin-based chemotherapy combined with atezolizumab in comparison to the carboplatin-based chemotherapy plus atezolizumab, similar results were obtained with cisplatin-based chemotherapy plus atezolizumab in PFS 8. 8 months, with cisplatin-based chemotherapy plus atezolizumab vs. 7. 1 months carboplatin/gemcitabine/atezolizumab. To increase the number of patients receiving cisplatin, a viable option may be to use split cisplatin with atezolizumab. The AUREA study is a multicenter, open labeled, multicohort Phase II clinical trial of atezolizumab in combination of split-dose cisplatin plus gemcitabine in patients with locally advanced or metastatic urothelial carcinomas. The dose schedule includes the initial dose of atezolizumab intravenously administered every 21 days up to disease progression, ineffective toxicity, or absence of clinical benefit. para m2 IV on D1 and 1000 mg/m2 IV of each 21-day cycle, plus Cisplatin 1000 mg/m2 IV on day 1 and 35 mg/m2 IV on day 8 for up to 6 cycles. Patients with progression were identified as per RECIST criteria at week 9, the PI of each site should assess the effectiveness of treatment with atezolizumab as per clinical benefit criteria.

Source link: https://clinicaltrials.gov/ct2/show/NCT04602078

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