Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

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: Part

Trial Details

NCT ID
NCT06228066
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • Lurbinectedin
  • Avelumab
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

  • Histologically or cytologically confirmed metastatic small cell carcinoma of the bladder (SCCB) or other high grade neuroendocrine tumors (HGNETs) …
  • Prior treatment as follows:
  • For Cohort 1: Participants must have received prior ICIs (PD-1 or PD-L1) or be ineligible for treatment with ICIs.
  • For Cohort 2: Participants must be ICI naive but eligible to receive them.

For full eligibility, visit ClinicalTrials.gov.

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