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Pembrolizumab + Lenvatinib for Bladder Cancer
Study Summary
This trial is testing whether adding lenvatinib to pembrolizumab improves survival in people with urothelial carcinoma who are ineligible for chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have moderate to severe numbness, tingling, or pain in my hands or feet.I had radiotherapy for cancer spread without certain drugs, except for bone treatment, within the last 3 weeks.I have been diagnosed with HIV.I have moderate to severe hearing loss.My blood pressure is under control.I meet the criteria for one of the specified options.My condition can be treated with the goal of curing it.I had chemo before bladder surgery and my cancer returned after a year.I have had or currently have lung inflammation treated with steroids.I have an immune system disorder or have been on steroids or immune-suppressing drugs in the last week.I have been treated with specific immune therapies for my cancer.I agree to use contraception or practice abstinence during and for 30 days after treatment.I had chemotherapy after bladder surgery and my cancer returned more than a year later.I am not pregnant or breastfeeding and will use birth control or abstain from sex during and after treatment.I have been treated with lenvatinib or anti-PD-1/PD-L1 drugs, or was in a lenvatinib study for bladder cancer.I have severe nerve damage or my cancer has spread to my internal organs.My organs are working well.I am allergic or have had a severe reaction to pembrolizumab or lenvatinib.I haven't had major heart problems in the last year.I can care for myself and doctors expect me to live at least 3 more months.I have not needed treatment for an autoimmune disease in the last 2 years.I have a severe fistula.I haven't had chemotherapy for advanced bladder cancer, with some exceptions.My cancer has invaded major blood vessels or caused significant bleeding recently.My tumor has neuroendocrine or small cell features.My physical health allows me to do some light activities.I have received a transplant from another person.You have at least one visible area of disease that can be measured by a doctor.I have moderate to severe hearing loss.You have taken part in a study involving an experimental drug within the past four weeks before the start of this study.I have provided a sample of my tumor for PD-L1 testing.My cancer is in the urinary tract and cannot be removed by surgery.I have a stomach or intestine condition that affects how I absorb pills.I am still recovering from major surgery complications.My brain metastases are stable, I finished local therapy and stopped steroids over 4 weeks ago.I am currently on medication for an infection.I have active tuberculosis.I am currently on hemodialysis.I have not had major surgery in the last 3 weeks.My cancer originates from the urinary system and cannot be surgically removed.I haven't had any cancer except for advanced bladder cancer in the last 3 years.I have not received a live vaccine in the last 30 days.
- Group 1: Pembrolizumab + Lenvatinib
- Group 2: Pembrolizumab + Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
What therapeutic effect does Lenvatinib typically have?
"Lenvatinib is most often associated with the treatment of malignant neoplasms; however, it has also been shown to be an effective for treating unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
What is the medical community's history with Lenvatinib?
"Out of the 1076 ongoing studies for Lenvatinib, 134 are in Phase 3. Most trials take place in Sacramento, California; however, there are 37362 locations worldwide running these types of experiments."
How many people are allowed to enroll in this clinical trial?
"As of 8/22/2022, this study is no longer actively recruiting patients. It was initially posted on 5/6/2019. If you are seeking other studies, there are presently 2597 trials actively enrolling participants with carcinoma and 1076 studies for Lenvatinib which are still searching for patients."
What are the goals of this research?
"The goal of this clinical trial is to assess the Overall Survival (OS) of patients over a period of approximately 40 months. Secondary outcomes include Time to Deterioration (TTD), Objective Response Rate (ORR), and Disease Control Rate (DCR). TTD will be determined by assessing the change in quality of life from baseline, with a longer TTD indicating a better outcome. ORR and DCR will be assessed based on RECIST 1.1 criteria by blinded independent central review."
Has the FDA cleared lenvatinib for use?
"Lenvatinib was rated a 3 on our company's 1-3 scale because it has progressed to Phase 3 trials. This suggests that not only is there some evidence of the drug's efficacy, but also that there are multiple rounds of data supporting its safety."
Are you still enrolling research volunteers for this project?
"According to the latest update on clinicaltrials.gov, this particular trial is not actively recruiting patients at this time. The trial was originally posted on May 6th, 2019 and was last updated on August 22nd, 2022. There are 3,673 other trials that are currently looking for participants."
In how many different medical facilities is this research being conducted today?
"New England Cancer Specialists (Site 0047), Karmanos Cancer Institute (Site 0712), and John Wayne Cancer Institute ( Site 0017) are 3 of the recruiting locations for this clinical trial. In total, there are 22 sites where patients can enroll in this study."
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