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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06228066
Phase
PHASE2
Status
Recruiting
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Conditions

  • High Grade Neuroendocrine Tumors of the Urinary Tract
  • Small Cell Carcinoma of the Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin — DRUG
    Lurbinectedin is administered IV over 1 hour at 3.2 mg/m\^2 on day 1 of each 21-day cycle
  • Avelumab — DRUG
    Avelumab is administered IV at 800 mg over 1 hour on day 1 of each 21-day cycle

Study Details

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.

Key Dates

Start date
Jun 13, 2024
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Treatment with lurbinectedin
  • Experimental: Arm 2
    Treatment with lurbinectedin and avelumab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: At every restaging (prior to every 3rd cycle) until the end of the treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Lisa Ley
[email protected]
240-858-3524
National Cancer Institute Referral Office
(888) 624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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