Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer.
NCT07207928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35
Last updated 2026-01-09
Summary
The goal of this observational study is to evaluate the clinical outcomes, side effects, and costs of Avelumab maintenance therapy in first-line and Pembrolizumab in second-line for platinum-fit patients with advanced urothelial cancer who have not shown disease progression after 4-6 cycles of platinum-based first-line chemotherapy.
Researchers will compare the effects of Avelumab (used as maintenance in first-line) and Pembrolizumab (used in second-line) to see if there are differences in clinical outcomes, toxicity profiles, and costs.
Participants will:
Receive Avelumab as maintenance therapy in the first-line or Pembrolizumab in the second-line as per standard clinical practice.
Be monitored for clinical outcomes, side effects, and costs over a period of up to 12 months prospectively and 10 years retrospectively.
Conditions
Sponsors & Collaborators
-
Ospedale Mater Salutis-Legnago(Verona), Italy
collaborator UNKNOWN -
Casa di Cura Dott. Pederzoli
collaborator OTHER -
Azienda Ospedaliera Universitaria Integrata Verona
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-16
- Primary Completion
- 2025-02-21
- Completion
- 2025-12-22
Countries
- Italy
Study Locations
More Related Trials
-
Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
NCT07225374 ·Status: RECRUITING ·Phase: PHASE2
-
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
NCT07221942 ·Status: RECRUITING ·Phase: PHASE2
-
Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
NCT03617913 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
NCT07129993 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Cryoablation With Pembrolizumab Or Avelumab In Urothelial Carcinoma
NCT04701918 ·Status: COMPLETED ·Phase: PHASE2
-
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
NCT05687721 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma
NCT03390595 ·Status: COMPLETED ·Phase: PHASE2
-
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
NCT06237920 ·Status: RECRUITING ·Phase: PHASE2
-
Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma
NCT07339878 ·Status: RECRUITING
-
Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo/Immunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W
NCT06686381 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
NCT05562830 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
NCT04617756 ·Status: RECRUITING ·Phase: PHASE2
-
Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma
NCT03287050 ·Status: TERMINATED ·Phase: PHASE2
-
Renal Retention in High Grade Upper Tract Urothelial Cancer
NCT05656235 ·Status: RECRUITING ·Phase: PHASE2
-
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
NCT03924895 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
NCT03288545 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
NCT07106762 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
NCT03244384 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder
NCT05137262 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer
NCT02662062 ·Status: COMPLETED ·Phase: PHASE2
-
Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo
NCT03421652 ·Status: COMPLETED ·Phase: PHASE2
-
Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma
NCT03534804 ·Status: COMPLETED ·Phase: PHASE2
-
Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer
NCT03272217 ·Status: TERMINATED ·Phase: PHASE2
-
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
NCT04887831 ·Status: TERMINATED ·Phase: PHASE2
-
Single-Dose Intravesical Chemotherapy After Diagnostic URS
NCT05810623 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3