A phase 1, non-randomized study of intravesical Enfortumab Vedotin for patients with BCG-unresponsive NMIBC
Study Details
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works.
All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.
Medical Condition
BCG-unresponsive NMIBC
Study Identifier
EV-104, SGN22E-004
NCT Number
NCT05014139
Study Phase
1
Get started
Answer a 2-minute questionnaire and speak to a study representative.
A first step as you consider connecting with a Principal Investigator is to answer a 2-minute online questionnaire about your interest and willingness to be contacted. If your answers show the study might be a good fit for you and your patient, you may choose to have your contact information shared with a study clinic that you select for further discussion.
Get connected.
Your answers to these questions will only be linked to you if your responses indicate that you would like to be connected with a Principal Investigator and you choose to share your contact information with the study clinic. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if your patient meets the study’s eligibility criteria and is able to enroll in the study.
Arms and Inverventions
The safety and efficacy of these investigational compounds, or investigational uses of marketed products, have not been established. For an agent(s) whose safety and efficacy have not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
References
ClinicalTrials.gov. A study of intravesical enfortumab vedotin for treatment of patients with non-muscle invasive bladder cancer (NMIBC) (08-20-2021). https://clinicaltrials.gov/ct2/show/nct05014139. Accessed 04-18-2024.