N-803 + Pembrolizumab + Enfortumab Vedotin for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of drugs to treat bladder cancer that has spread locally or to other parts of the body. The goal is to evaluate how well the drugs N-803 (an experimental treatment), pembrolizumab, and enfortumab vedotin work together against this type of cancer. People with bladder cancer who have not received other systemic treatments and can manage regular visits might be suitable for this trial. Participants will receive these treatments in three-week cycles, repeated until the cancer progresses or side effects become too severe. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires that participants strongly consider stopping beta-blockers when starting N-803, but they can continue if necessary. If you're on corticosteroids or other immunosuppressive agents, you must stop them at least 1 week before joining the trial if used recently, or 4 weeks if used long-term. The protocol doesn't specify other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that enfortumab vedotin is generally safe for people with advanced bladder cancer and can extend survival compared to standard treatments. However, it may cause side effects, such as skin reactions and high blood sugar.
Studies have found that N-803 is safe to use. When combined with other treatments, it has caused few unexpected side effects, which are mostly manageable and similar to those of other treatments.
Pembrolizumab is already approved for treating advanced bladder cancer. It is usually well-tolerated, but some patients may experience immune-related side effects, such as inflammation in organs like the lungs or liver.
Overall, each treatment has a good safety record. The trial will closely monitor participants to manage any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of N-803, Enfortumab Vedotin, and Pembrolizumab for bladder cancer because it offers a unique multi-target approach. Unlike standard treatments like chemotherapy, which broadly attack rapidly dividing cells, Enfortumab Vedotin is an antibody-drug conjugate that specifically targets cancer cells with a protein called Nectin-4, while N-803 is designed to enhance the immune response against cancer cells. Pembrolizumab, an immunotherapy, further boosts this effect by helping the immune system recognize and attack cancer cells. This combination aims to be more precise and potentially more effective, with the possibility of fewer side effects compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research has shown that enfortumab vedotin helps patients with advanced bladder cancer live longer compared to standard chemotherapy. In this trial, participants will receive a combination of enfortumab vedotin, pembrolizumab, and N-803. Combining enfortumab vedotin with pembrolizumab has shown promising results, further improving survival rates for those with metastatic cancer. Pembrolizumab alone is associated with longer survival and fewer side effects in patients with advanced bladder cancer. N-803, when used with another bladder cancer treatment, successfully removed cancer in many patients and prevented its return for a long time. These findings suggest that using these treatments together may effectively combat advanced bladder cancer.23678
Who Is on the Research Team?
Vadim Koshkin, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Adults with locally advanced or metastatic urothelial carcinoma, not previously treated systemically for this stage. Must have measurable disease, adequate organ function, and no severe allergies to trial drugs. HIV-positive participants are eligible if viral load is undetectable. Prior perioperative therapy is allowed if completed over a year ago. Participants must be able to provide informed consent and agree to effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive N-803, Enfortumab Vedotin, and Pembrolizumab in a repeated 3-week cycle until disease progression or unacceptable toxicity, up to 12 cycles
Extended Treatment
Participants with confirmed clinical benefit may continue treatment with N-803 and Pembrolizumab for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment, with survival follow-up until death or end of study
What Are the Treatments Tested in This Trial?
Interventions
- Enfortumab Vedotin
- N-803
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vadim S Koshkin
Lead Sponsor
ImmunityBio, Inc.
Industry Sponsor
Richard Adcock
ImmunityBio, Inc.
Chief Executive Officer since 2024
Information not available
Dr. Patrick Soon-Shiong
ImmunityBio, Inc.
Chief Medical Officer since 2021
MD