Clinical Trials Logo
  1. Home
  2. Urothelial Cancer
  3. NCT05366725

A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

Urothelial Cancer Clinical Trial

Official title:
A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR THE FIRST-LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY

Clinical Trial Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsened after receiving chemotherapy. This study is seeking participants who: 1. Have UC that cannot be operated on or has spread to other parts of the body 2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment 3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy 4. Are 18 years or older on the date that they start taking Avelumab All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.

Clinical Trial Description

The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy. The secondary objectives are: 1. To describe the clinical and demographic characteristics of the study population 2. To estimate real-world progression-free survival (rwPFS) 3. To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy 4. To describe treatment patterns after initiation of avelumab as 1L maintenance therapy 5. To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population 6. To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05366725
Study type Observational
Source Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Contact
Status Active, not recruiting
Phase
Start date June 29, 2022
Completion date November 30, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Terminated NCT01663285 - Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC) Phase 2
Recruiting NCT00872495 - Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
Terminated NCT04629339 - Study of INCB086550 in Select Solid Tumors Phase 2
Recruiting NCT04114136 - Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2
Completed NCT03219333 - A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer Phase 2
Terminated NCT04501094 - A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma Phase 2
Recruiting NCT04923178 - A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
Completed NCT02256436 - A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045) Phase 3
Completed NCT01206426 - Genetic Determinants of Response to Neoadjuvant Cisplatin-based Chemotherapy in Urothelial Cancer
Terminated NCT00995488 - Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer Phase 2
Active, not recruiting NCT03425201 - Niraparib in Combination With Cabozantinib (XL184) in Patients With Advanced Urothelial Cancer (NICARAGUA) Phase 1/Phase 2
Active, not recruiting NCT03288545 - A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer Phase 1/Phase 2
Active, not recruiting NCT03983954 - Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT04180371 - Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression Phase 1/Phase 2
Active, not recruiting NCT02891161 - Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder Phase 1/Phase 2
Withdrawn NCT01700010 - Trial of Lapatinib and Weekly Paclitaxel for Advanced Urothelial Cancer Phase 2
Active, not recruiting NCT02516241 - Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Phase 3
Active, not recruiting NCT04152018 - Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. Phase 1