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New treatment option for Small Cell Carcinoma of the Bladder
Official title Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
ClinicalTrials.gov ID: NCT06228066
What this study is testing
What is Lurbinectedin?
Lurbinectedin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell carcinoma of the bladder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histologically or cytologically confirmed metastatic small cell carcinoma of the bladder (SCCB) or other high grade neuroendocrine tumors (HGNETs) of...
- 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.
- Participants must have metastatic disease defined as new or progressive lesions.
You likely can't join if
- Prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 14...
- Participants previously treated with lurbinectedin.
- History of anaphylactic allergic reactions attributed to compounds of similar chemical or biologic composition to lurbinectedin or avelumab
- Symptomatic or untreated CNS metastases
- For Cohort 2: Active autoimmune disease that might deteriorate when receiving avelumab with the exception of:
- Diabetes type I, eczema, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed metastatic small cell carcinoma of the bladder (SCCB) or other high grade neuroendocrine tumors (HGNETs) of the urinary tract (which includes renal pelvis, ureter, and urethra...
- 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.
- Participants must have metastatic disease defined as new or progressive lesions.
- Participants must have at least one measurable site of disease, per RECIST 1.1.
- Participants must have received, be ineligible, or refused prior platinum/etoposide chemotherapy for SCCB or other HGNET of the urinary tract. Platinum ineligibility is defined as a CrCl \ =2, hearing loss \>= grade 2...
- Age \>=18 years.
- Eastern Cooperative Oncology Group [ECOG] performance status (PS) \ =60%).
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) \>=1,500/microliter
- Platelets \>=100,000/ microliter
- Hemoglobin (Hgb) \> 9g/dL (erythrocyte transfusions are allowed to achieve acceptable Hgb)
- Total bilirubin within normal limits with the following exceptions:
- Participants with tumor involving the liver may have mild to moderate hepatic impairment with total bilirubin \<= 1.5 x upper limit of normal (ULN)
- Participants with known Gilbert disease who have serum bilirubin level \<= 1.5 x ULN
- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \<=1.5 x institutional ULN ---Participants with tumor involving the liver with AST and ALT \<= 5.0 x ULN and bilirubin \<= 1.5 x ULN may be eligible.
- Creatinine clearance (CrCl) \>= 30 mL/min/1.73 m\^2 (glomerular filtration rate [GFR] may be used in place of CrCl. Creatinine clearance or eGFR should be calculated per institutional standard)
- Creatine phosphokinase (CPK) \<= 2.5 x ULN
- Participants with previously treated brain metastases or central nervous system (CNS) metastases are eligible if they have recovered from any acute effects of radiotherapy and not requiring steroids, and any whole brain...
- Human immunodeficiency virus (HIV) positive participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), CD4 counts are \> 350 cells/mm\^3 and viral load is undetectable.
- Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry and with planned monitoring and management according to appropriate...
- Hepatitis C virus (HCV) positive participants are eligible if:
- they are on active HCV therapy at study entry or are on an appropriate course of antivirals without documented clinically significant impaired liver function test or hematologic abnormalities and with planned monitoring...
- they have a negative polymerase chain reaction (PCR).
- Systemic corticosteroid therapy (defined as \>= the equivalent of prednisone 10 mg/day) or other immunosuppressive agents such as azathioprine or cyclosporin must be discontinued at least 1 week prior to treatment...
- Contraception requirements as follows: Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device [IUD], hormonal, surgical sterilization...
- Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through six (6) weeks after the last dose of the study drug(s).
- Participants must be able to understand and willing to sign a written informed consent document.
What rules you out
- Prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 14 days prior to the first drug administration. Additionally, FDA-approved...
- Participants previously treated with lurbinectedin.
- History of anaphylactic allergic reactions attributed to compounds of similar chemical or biologic composition to lurbinectedin or avelumab
- Symptomatic or untreated CNS metastases
- For Cohort 2: Active autoimmune disease that might deteriorate when receiving avelumab with the exception of:
- Diabetes type I, eczema, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment
- Requirement of hormone replacement with corticosteroids if the steroids are administered only for the purpose of hormonal replacement and at doses \<= 10mg of prednisone or equivalent per day
- Requirement of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation)
- Physiologic doses of corticosteroids (\<= the equivalent of prednisone 10 mg/day). The use of corticosteroids as premedication for contrast-enhanced studies is allowed prior to treatment initiation and on study.
- Prior organ transplantation including allogenic stem cell transplantation.
- Participants who have received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus and locally...
- Pregnant people as evaluated by a positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test
- Severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.