Table of Contents
- Trial overview
- Who is being studied
- How the studies are designed
- Main endpoints and what they mean
- Key Vinflunine trial settings
- What the trial results focus on
Trial overview
The trial data show Vinflunine being studied in urothelial cancer, especially when the cancer is locally advanced, metastatic, or unresectable.[1][2][3][4]
All listed studies are Phase 3 trials, which are larger studies used to compare treatment options and measure how well they work in real patient groups.[1][2][3][4]
The studies are completed or authorised, and they mostly compare Vinflunine with other cancer treatments rather than testing it alone.[1][2][3][4]
Who is being studied
The target population is adults with advanced bladder or urinary tract cancer, described in the records as advanced urothelial cancer or urothelial carcinoma.[2][4]
Some trials focus on people whose cancer has already progressed after earlier treatment, which means the disease got worse even after prior therapy.[2][4]
One study includes people with locally advanced or metastatic unresectable disease, meaning the cancer cannot be removed by surgery and may have spread.[1]
Another study separates patients into cohorts based on whether they previously received an anti-PD-(L)1 treatment, which is a treatment history detail used to guide the comparison groups.[2]
How the studies are designed
The studies are interventional trials, meaning researchers assign treatments and then watch what happens.[1][2][3][4]
One trial is randomized and open-label, which means patients are placed into treatment groups by chance and both the doctors and patients know which treatment is being given.[1]
Several studies compare Vinflunine with other options such as docetaxel, paclitaxel, pembrolizumab, or investigator’s choice chemotherapy.[2][3][4]
In one study, Vinflunine is listed as part of the chemotherapy choices in the comparison arm for patients with prior anti-PD-(L)1 treatment.[2]
Main endpoints and what they mean
The main endpoint in these studies is overall survival, often shortened to OS.[1][2][3][4]
Overall survival means the time from the start of the study treatment, or from randomization in one trial, until death from any cause.[2]
This endpoint is important because it shows whether one treatment helps patients live longer than another treatment.[1][3][4]
Key Vinflunine trial settings
NCT04527991 is a Phase 3 randomized open-label study in people with metastatic or locally advanced unresectable urothelial cancer, and it compares sacituzumab govitecan with treatment of physician’s choice.[1]
2023-510296-56-00 is a Phase 3 study in advanced urothelial cancer with selected FGFR changes, and it compares erdafitinib with chemotherapy or pembrolizumab depending on prior treatment history.[2]
In the chemotherapy comparison for Cohort 1, the record names docetaxel or Vinflunine as the chemotherapy options.[2]
2024-517571-20-00 is a Phase 3 study in previously treated locally advanced or metastatic urothelial cancer, comparing enfortumab vedotin with chemotherapy options that include Vinflunine, docetaxel, and paclitaxel.[3]
2024-520014-22-00 is an authorised Phase 3 trial in locally advanced or metastatic urothelial carcinoma, comparing sacituzumab tirumotecan with investigator’s choice nonplatinum chemotherapy, with Vinflunine listed among the options.[4]
What the trial results focus on
These studies are mainly trying to find out whether the tested treatment improves survival compared with the control treatment.[1][2][3][4]
They also show how Vinflunine is being used in research as a chemotherapy choice for advanced urothelial cancer, especially after earlier treatment has not worked well enough.[2][3][4]
Because the studies are Phase 3 and include larger patient groups, they are designed to give stronger answers about which treatment approach may be better for these patients.[1][2][3][4]
