Conditions
Urinary Bladder Cancer, Muscle-invasive
Trial Purpose
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.
With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.
With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.
NATIONAL TRIAL REFERENCE NUMBER
NCT03924895
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About The Study
All patients who enroll in the trial will receive medication while on the study.
33% will receive pembrolizumab before and after surgery
33% will receive standard of care surgery only
33% will receive pembrolizumab along with enfortumab vedotin before and after surgery
Trial Phase
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Actual study start date July 24, 2019
- Estimated primary completion date May 31, 2027
- Estimated study completion date December 15, 2027
Trial Locations
Sorry, there are no locations found.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about