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Lurbinectedin + Avelumab for Bladder Cancer
Study 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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is this experimental treatment still taking on new participants?
"This medical trial, which was publicly announced on 8th May 2023, is presently searching for participants. The posted information has been amended as of the same date."
Is the combination of avelumab and lurbinectedin considered safe for humans?
"Although there is evidence of avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin being safe, its efficacy has yet to be confirmed. Thus, it received the score of 2 on our team's safety scale."
What is the current participant count of this experiment?
"Affirmative. Clinicaltrials.gov indicates that this biomedical research, which was initially publicized on May 8th 2023, is still searching for participants. A total of 36 volunteers need to be recruited from a single medical centre."
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