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Monoclonal Antibodies

Arm 1 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.

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

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Clinical benefit rate (CBR)

Duration of response (DoR)

Overall survival (OS)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment2 Interventions

Treatment with lurbinectedin and avelumab

Group II: Arm 1Experimental Treatment1 Intervention

Treatment with lurbinectedin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lurbinectedin

2022

Completed Phase 2

~90

Avelumab

2018

Completed Phase 2

~2450

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,685 Previous Clinical Trials

40,930,294 Total Patients Enrolled

Andrea B Apolo, M.D.Principal InvestigatorNational Cancer Institute (NCI)

11 Previous Clinical Trials

1,333 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks or adverse effects associated with Arm 1 for individuals?

"Based on the nature of this Phase 2 trial, Arm 1 received a safety rating of 2 from our team at Power. While there is some evidence supporting its safety, no data has been found yet to support its effectiveness."

Answered by AI

Which individuals meet the eligibility criteria for participation in this investigation?

"To be eligible for inclusion in this research study, patients must have a diagnosis of neuroendocrine carcinoma and fall within the age range of 18 to 120 years. The trial has capacity for approximately 35 participants."

Answered by AI

Is the enrollment for this study currently available to prospective participants?

"According to the information available on clinicaltrials.gov, this particular trial is not currently accepting new participants. The trial was originally posted on February 1st, 2024 and was last updated on January 26th, 2024. However, it's worth noting that there are presently 3084 other ongoing clinical trials actively seeking individuals for participation."

Answered by AI

Is the trial open to individuals aged 45 and above?

"To be considered for this clinical trial, potential participants must fall within the age range of 18 to 120. Notably, there are currently 103 ongoing trials specifically targeting patients under the age of 18 and an additional 3054 trials focusing on patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06228066.