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Tyrosine Kinase Inhibitor
Pembrolizumab + Lenvatinib for Bladder Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy
NCI CTCAE Version 4.0 Grade ≥2 audiometric hearing loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~60 months
Awards & highlights
Study Summary
This trial is testing whether adding lenvatinib to pembrolizumab improves survival in people with urothelial carcinoma who are ineligible for chemotherapy.
Who is the study for?
This trial is for adults with advanced or metastatic urothelial carcinoma who can't have cisplatin-based chemotherapy. They must have a specific level of PD-L1 protein expression, be able to provide tissue samples, and not be pregnant or breastfeeding. Participants need controlled blood pressure, adequate organ function, and no severe hearing loss or neuropathy.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of combining lenvatinib with pembrolizumab versus pembrolizumab with a placebo in treating bladder cancer. The main goals are to see if this combination improves survival without disease progression and overall survival time.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs, fatigue, skin rash, digestive issues like diarrhea or nausea, high blood pressure, liver problems (hepatitis), kidney issues including failure, hormonal gland changes (thyroid/adrenal), and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I have moderate to severe hearing loss.
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I agree to use contraception or practice abstinence during and for 30 days after treatment.
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I have severe nerve damage or my cancer has spread to my internal organs.
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I can care for myself and doctors expect me to live at least 3 more months.
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My physical health allows me to do some light activities.
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I have moderate to severe hearing loss.
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I have provided a sample of my tumor for PD-L1 testing.
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My cancer is in the urinary tract and cannot be removed by surgery.
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My cancer originates from the urinary system and cannot be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS)
Secondary outcome measures
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib and participants who remain on treatment will receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Group II: Pembrolizumab + PlaceboActive Control2 Interventions
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo and participants who remain on treatment will receive open label pembrolizumab only, at the same dose and schedule (IV 200 mg on Day 1 of each 21-Day cycle for up to 35 cycles [up to ~2 years]).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,485 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,908 Previous Clinical Trials
5,066,159 Total Patients Enrolled
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
158,546 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Placebo
- Group 2: Pembrolizumab + Lenvatinib
Awards:
This trial has 3 awards, including:- 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.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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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