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PD-L1 Inhibitor
Lurbinectedin + Avelumab for Bladder Cancer
Phase 2
Waitlist Available
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore a combination of immunotherapy and chemotherapy as a new treatment for advanced bladder cancer that is stable or responding to initial chemotherapy.
Who is the study for?
Adults over 18 with advanced bladder cancer that hasn't spread after initial chemo can join this trial. They need to have finished 4-6 cycles of platinum-based chemo, be in stable condition or responding well to treatment, and have good organ function. Pregnant women can't participate, and those who can have children must use effective birth control.
What is being tested?
The trial is testing a combination of avelumab (an immunotherapy drug) and lurbinectedin as maintenance therapy for patients whose bladder cancer didn't worsen after first-line chemotherapy. It's not randomized; all participants receive the same treatment.
What are the potential side effects?
Avelumab may cause immune-related side effects like skin reactions, thyroid issues, or inflammation in organs such as lungs or intestines. Lurbinectedin could lead to blood cell count changes, fatigue, liver enzyme alterations, nausea or vomiting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The combination of lurbinectedin chemotherapy with maintenance avelumab immunotherapy in patients with advanced cancer of the urinary tract
Secondary study objectives
Overall Survival (OS)
The secondary objectives of this study are to assess
Therapeutic procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedinExperimental Treatment1 Intervention
Phase II trial is designed to evaluate the combination of avelumab (800 mg IV every 2 weeks-(days 1,15, and 29 every 6 week cycle ) and lurbinectedin (3·2 mg/m2 lurbinectedin administered as a 1-h intravenous infusion once every 3 weeks-day 1 and 22 every 6 week cycle ) for those with stable or responding disease following 4-6 cycles of platinum-based firstline chemotherapy for mUC with stable or responding disease following 4-6 cycles of platinum-based firstline chemotherapy for mUC.
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Who is running the clinical trial?
AdventHealthLead Sponsor
115 Previous Clinical Trials
31,365 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
249 Previous Clinical Trials
34,841 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been diagnosed with any cancer other than NSCLC in the past 2 years.I have previously received immunotherapy.I can take care of myself and perform daily activities.I need steroids for my brain metastases symptoms.I had initial cancer treatment before or after surgery within the last year.My liver is working well.I am currently on medication for an infection.I have a history of immunodeficiency or an organ transplant and need immunosuppressive therapy.My kidney function is normal.I can provide a recent tissue sample from my cancer before starting chemotherapy.I completed 4-6 cycles of platinum-based chemotherapy 4-10 weeks ago.My blood tests show my bone marrow is working well.I have not had a heart attack or stroke in the last 6 months.I have not had major surgery in the last 4 weeks or major radiation in the last 2 weeks.My cancer is advanced and cannot be removed by surgery.My cancer was at stage IV when I started my first chemotherapy.I have not received any vaccines within 4 weeks before starting the study treatment.I haven't taken immunosuppressive drugs in the last week, except for certain exceptions.I have an autoimmune disease that could worsen with immune-stimulating treatments.I have lasting side effects from previous treatments that are moderate to severe.I am older than 18 years.I am not pregnant, breastfeeding, and if capable of having children, I agree to use two effective birth control methods.My bladder cancer has worsened after initial chemotherapy.My cancer did not worsen after 4-6 rounds of initial chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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