Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with a type of bladder cancer called small cell carcinoma, or a similar high-grade neuroendocrine tumor in the urinary tract (such as in the kidney, ureter, or urethra — but not the prostate), confirmed by a tissue or cell sample. Mixed tumors that include these cancer types also qualify.
• Depending on which group (cohort) you are assigned to: either you have already received a type of immunotherapy called an immune checkpoint inhibitor (ICI), or you are not able to receive it — OR you have never received this type of immunotherapy but are eligible to receive it.
• Your cancer has spread (metastatic) and is showing new or growing areas.
• You have at least one area of cancer that can be measured on a scan, according to standard medical guidelines.
• You have already received, were unable to receive, or chose not to receive a standard chemotherapy combination (platinum and etoposide) for your cancer.
• You are 18 years of age or older.
• You are well enough to carry out daily activities, based on a standard health scoring system (confirm with trial site).
• Your blood counts, liver, and kidney function meet certain minimum levels based on blood tests (confirm with trial site for specific numbers).
• If you previously had cancer spread to the brain, it has been treated, you have recovered from any side effects of that treatment, you are no longer on steroids for it, and your brain radiation was completed at least 2 weeks before starting the trial.
• If you are HIV-positive, your HIV is well controlled on medication, your immune cell count is above a certain level, and the virus is undetectable in your blood.
• If you have hepatitis B, you are being treated or monitored appropriately.
• If you have hepatitis C, you are on treatment, have completed treatment, or have tested negative for the virus.
• Any steroid medications (at higher than low doses) or immune-suppressing drugs you were taking have been stopped for at least 1 week (if used short-term) or 4 weeks (if used long-term) before starting the trial.
• If you are able to become pregnant, you agree to use a highly effective form of birth control during the trial and for 6 months after your last dose.
• If you are able to father a child, you agree to use effective birth control during the trial and for 6 months after your last dose, and you will not donate or freeze sperm during this time.
• If you are currently breastfeeding, you are willing to stop from the start of treatment until 6 weeks after your last dose.
• You are able to understand and willing to sign a consent form agreeing to take part in the trial.

Who may not be able to join:

• You have received any experimental drug, chemotherapy, immunotherapy, or radiation therapy (other than radiation aimed at bone pain) within the 14 days before starting the trial.
• You have previously been treated with the drug lurbinectedin (one of the drugs used in this trial).
• You have had a severe allergic reaction to a drug that is chemically similar to lurbinectedin or avelumab (the two study drugs).
• Your cancer has spread to the brain and is currently causing symptoms, or has not yet been treated.
• For the group receiving immunotherapy (Cohort 2): you have an active autoimmune disease (a condition where your immune system attacks your own body) that could get worse with treatment — with some exceptions for mild or well-controlled conditions like type 1 diabetes, eczema, vitiligo, psoriasis, or thyroid conditions that do not require immune-suppressing treatment (confirm with trial site for full list of exceptions).
• You have had an organ transplant or a bone marrow/stem cell transplant from another person.
• You have received or are planning to receive a live vaccine within 30 days before starting the trial (standard flu shots without live virus and approved COVID-19 vaccines are allowed).
• You are currently pregnant, as confirmed by a blood or urine test.
• You have a serious uncontrolled illness that would make it difficult to follow the trial requirements (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.