Actively Recruiting
Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
Led by National Cancer Institute (NCI) · Updated on 2026-03-23
45
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Small cell carcinoma of the bladder (SCCB) and other high-grade neuroendocrine tumors (HGNET) of the urinary tract are rare but aggressive cancers. Average survival for people diagnosed with SCCB or HGNET is about 1 year. Lurbinectedin and avelumab are drugs that are approved to treat other cancers. Researchers want to see if these drugs can help people with SCCB or HGNET. Objective: To test lurbinectedin with or without avelumab in people with SCCB or HGNET. Eligibility: Adults aged 18 years and older with SCBB or HGNET that returned and spread after treatment. Design: Participants will be screened. They will have a physical exam. They will have blood tests and imaging scans. They may need to have a new biopsy: A small needle will be used to collect a tissue sample from the tumor. Both study drugs are given through a tube attached to a needle inserted into a vein. If participants have already received a drug like avelumab they will receive only lurbinectedin. If patients have not been previously treated with a drug like avelumab they will receive both lurbinectedin and avelumab. All participants will receive their treatment once every 3 weeks for up to 10 years. They will also receive other drugs to relieve adverse effects. Biopsies, blood tests, and imaging scans will be repeated during some study visits. Participants may also have urine tests and tests of their heart function. Participants may remain in the study as long as the treatment is helping them. If they stop treatment, they will have safety visits 14, 30, and 90 days after their last dose. Additional follow-up visits will continue 5 to 10 years.
CONDITIONS
Official Title
Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic small cell carcinoma of the bladder or other high-grade neuroendocrine tumors of the urinary tract
- Prior treatment: either previously treated with immune checkpoint inhibitors or ineligible for them (Cohort 1), or immune checkpoint inhibitor naive but eligible (Cohort 2)
- Metastatic disease with new or progressive lesions
- At least one measurable site of disease per RECIST 1.1 criteria
- Received, ineligible for, or refused prior platinum/etoposide chemotherapy
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky score 60% or higher)
- Adequate organ and marrow function including ANC ≥1,500/microliter, platelets ≥100,000/microliter, hemoglobin >9 g/dL
- Total bilirubin within normal limits or mild to moderate impairment under defined conditions
- AST and ALT ≤1.5 times upper limit of normal (may be higher if liver tumor involvement)
- Creatinine clearance ≥30 mL/min/1.73 m²
- Creatine phosphokinase ≤2.5 times upper limit of normal
- Previously treated brain metastases allowed if stable and off steroids
- HIV positive participants on stable therapy with CD4 counts >350 cells/mm³ and undetectable viral load
- Hepatitis B or C positive participants under appropriate monitoring or treatment
- Discontinued systemic corticosteroids or immunosuppressive agents as specified prior to treatment
- Use of effective contraception during and up to six months after study participation
- Willingness to discontinue nursing during treatment and for six weeks afterward
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior investigational drug, chemotherapy, immunotherapy, or radiotherapy (except palliative bone therapy) within 14 days before first dose
- Previous treatment with lurbinectedin
- History of severe allergic reactions to lurbinectedin or avelumab
- Symptomatic or untreated central nervous system metastases
- Active autoimmune disease that may worsen with avelumab treatment, except certain controlled conditions
- Prior organ or stem cell transplantation
- Receipt of live vaccines within 30 days prior to first dose (seasonal flu and approved COVID-19 vaccines allowed)
- Pregnancy
- Severe uncontrolled illnesses that would limit study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCIMO Referral Office
CONTACT
A
Andrea B Apolo, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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