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Monoclonal Antibodies

Lurbinectedin + Avelumab for Bladder Cancer

Phase 2

Recruiting

Led By Andrea B Apolo, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years.

Participants must have metastatic disease defined as new or progressive lesions.

Must not have

Symptomatic or untreated CNS metastases

Participants with prior organ transplantation including allogenic stem cell transplantation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each study visit and at every restaging (every 9 weeks) starting at cycle 3 until pd

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of two drugs, lurbinectedin and avelumab, in treating a rare and aggressive form of bladder and urinary tract cancer. The drugs will be given to

Who is the study for?

This trial is for adults over 18 with Small Cell Carcinoma of the Bladder (SCCB) or high-grade neuroendocrine tumors (HGNET) in the urinary tract that have worsened and spread post-treatment. Participants must be able to undergo a biopsy, blood tests, imaging scans, and possibly heart function tests.

What is being tested?

The study is examining the effectiveness of Lurbinectedin alone versus combined with Avelumab in treating SCCB or HGNET. Treatments are administered intravenously every three weeks for up to ten years, alongside drugs to mitigate side effects.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Heart function may also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer has spread and is getting worse.

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I can take care of myself but might not be able to do heavy physical work.

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My kidney function, measured by creatinine clearance or GFR, is adequate.

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I agree to use effective birth control during and up to 6 months after the study.

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I have a confirmed diagnosis of a high-grade neuroendocrine tumor in my urinary tract.

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I have either been treated with immune checkpoint inhibitors or cannot receive such treatment.

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I had brain metastases treated and am not on steroids, with my last brain radiation over 2 weeks ago.

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I agree to use effective birth control during and up to 6 months after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that are causing symptoms or have not been treated.

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I have had an organ or stem cell transplant.

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I have been treated with lurbinectedin before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at each study visit and at every restaging (every 9 weeks) starting at cycle 3 until pd

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at each study visit and at every restaging (every 9 weeks) starting at cycle 3 until pd

This trial's timeline: 3 weeks for screening, Varies for treatment, and at each study visit and at every restaging (every 9 weeks) starting at cycle 3 until pd for reporting.