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NCT06228066 · ClinicalTrials.gov registry record · Phase 2
Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
A Phase 2 study of Small Cell Carcinoma of the Bladder and High Grade Neuroendocrine Tumors of the Urinary Tract, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06228066: Recruiting Phase 2 study of Small Cell Carcinoma of the Bladder and High Grade Neuroendocrine Tumors of the Urinary Tract, sponsored by National Cancer Institute (NCI).
NCT06228066 is a Phase 2 study of Small Cell Carcinoma of the Bladder and High Grade Neuroendocrine Tumors of the Urinary Tract that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06228066, a Phase 2 study of Small Cell Carcinoma of the Bladder and High Grade Neuroendocrine Tumors of the Urinary Tract, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Percentage of participants by best overall response (e.g., CR, PR, SD, PD) to therapy
Conditions Studied
Interventions
- DRUG Avelumab
- DRUG Lurbinectedin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-06-13 |
| Est. Completion | 2028-09-01 |
| Phase | Phase 2 |
What NCT06228066 shows while recruiting
NCT06228066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Small Cell Carcinoma of the Bladder appearing as the primary indexed condition, and to 2 interventions - of which Avelumab is the first listed.
NCT06228066 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06228066 about?
NCT06228066 is a clinical study titled "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 o...
What is the current status of trial NCT06228066?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2024-06-13. Estimated completion is 2028-09-01.
What conditions does trial NCT06228066 study?
This clinical trial studies the following conditions: Small Cell Carcinoma of the Bladder, High Grade Neuroendocrine Tumors of the Urinary Tract.
What interventions are being tested in trial NCT06228066?
The interventions under investigation include: Avelumab (DRUG), Lurbinectedin (DRUG).
Who is sponsoring clinical trial NCT06228066?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06228066 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06228066's enrollment target sits among peer trials
45 1296th of 2000 higher than 680 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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