CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Avelumab +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03617913
NCT03617913Phase 2Completed

Phase II Study Evaluating Combination Chemotherapy + Radiotherapy (RT) With Avelumab in Muscle Invasive Bladder Cancer

Mayo Clinic·interventional·Posted Aug 7, 2018·Updated Jan 6, 2023

In Brief

A Phase 2 clinical trial evaluating Avelumab, Cisplatin, and 4 other interventions for Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall and 11 related conditions. Completed, enrolled 2 participants across 3 sites.

Detailed Summary

This phase II trial studies the side effects of avelumab and how well it works in combination with fluorouracil and mitomycin or cisplatin and radiation therapy in treating participants with muscle-invasive bladder cancer. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving avelumab with chemotherapy and radiotherapy may work better in treating participants with muscle-invasive bladder cancer.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 7, 2018
Enrollment StartSep 19, 2018
Primary CompletionNov 14, 2019
Study CompletionJul 27, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.9 years ago

Interventions

Avelumabdrug

Given IV

Cisplatindrug

Given IV

Fluorouracildrug

Given IV

Mitomycindrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Radiation Therapyradiation

Undergo RT