Study on Treatment Combinations for Muscle Invasive Bladder Cancer Patients Who Cannot or Choose Not to Use Cisplatin
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04960709
This clinical trial is testing new treatment combinations for patients with muscle invasive bladder cancer who cannot use or choose not to use the chemotherapy drug cisplatin. The study compares the effectiveness and safety of two different combinations of medications given before and after surgery.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring two new treatment combinations for patients with muscle invasive bladder cancer who are either unable to use or choose not to use cisplatin, a common chemotherapy drug. The trial will test the effectiveness and safety of combining Durvalumab with Tremelimumab and Enfortumab Vedotin, or Durvalumab with Enfortumab Vedotin, compared to the current standard treatment. The study is divided into two parts: a Safety Run-In and the Main Study, aiming to enroll about 677 patients. Participants will be randomly assigned to receive one of the new treatment combinations or the standard treatment. Those in the treatment groups will receive three cycles of the medications before surgery and continue with Durvalumab after surgery.
Description
Not provided
Eligibility Criteria
Inclusion Criteria
- Diagnosed with muscle-invasive bladder cancer confirmed by lab tests.
- Have transitional cell or mixed cell types of bladder cancer.
- Cancer stage must be T2-T4aN0/1M0 or T1N1M0 (T1 stage only if N1 disease is present).
- Have not received prior chemotherapy or immunotherapy for muscle invasive bladder cancer.
- Medically fit for surgery and able to receive treatment before surgery.
- ECOG performance status of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Must provide a tumor sample before starting the study.
- Expected to live at least 12 weeks after randomization.
- Cannot use cisplatin due to medical reasons or choose not to use it (must be documented in medical records).
Exclusion Criteria
- Cancer has spread to lymph nodes (N2+) or other parts of the body at screening.
- Have an active infection.
- Have uncontrolled illnesses.
- Have previously received immune therapy (except BCG) or similar treatments.
- Currently using or have recently used immunosuppressive medications within 14 days before starting the study.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.