At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic small cell carcinoma of the bladder (SCCB) or high grade neuroendocrine tumors (HGNETs) of urinary tract
- ✓Mixed histologies with SCCB or HGNET component eligible
- ✓Cohort 1: Prior ICI (PD-1 or PD-L1) treatment or ICI-ineligible
- ✓Cohort 2: ICI-naive but eligible for ICI treatment
- ✕Prior investigational drug, chemotherapy, immunotherapy, or radiotherapy (except palliative bone-directed) within 14 days
- ✕Previously treated with lurbinectedin
- ✕Anaphylactic allergic reactions to compounds similar to lurbinectedin or avelumab
- ✕Symptomatic or untreated CNS metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
In Brief
A Phase 2 clinical trial evaluating Lurbinectedin and Avelumab for Small Cell Carcinoma of the Bladder and High Grade Neuroendocrine Tumors of the Urinary Tract. Currently recruiting, targeting 45 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Treatment with lurbinectedin
Treatment with lurbinectedin and avelumab
Interventions
Lurbinectedin is administered IV over 1 hour at 3.2 mg/m\^2 on day 1 of each 21-day cycle
Avelumab is administered IV at 800 mg over 1 hour on day 1 of each 21-day cycle