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mTOR Inhibitor
Combination Therapy vs Standard Treatment for Kidney Cancer (CLEAR Trial)
Phase 3
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological confirmation of RCC with a clear-cell component (original tissue diagnosis of RCC is acceptable)
Documented evidence of advanced RCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization to the date of the first documentation of pd or date of death, whichever occurred first or up to data cutoff date 28 aug 2020 (up to approximately 46 months)
Awards & highlights
CLEAR Trial Summary
This trial is testing whether two different cancer drugs are better than one common cancer drug for treating kidney cancer.
Who is the study for?
This trial is for adults with advanced renal cell carcinoma who have not had systemic cancer treatment for RCC. They must have at least one measurable lesion, be in good physical condition (KPS >=70), and have stable blood pressure and organ functions. Pregnant or breastfeeding women, those unwilling to use contraception, or individuals with certain medical conditions like CNS metastases, severe bleeding risks, recent live vaccines, uncontrolled diabetes, significant heart issues within the past year are excluded.Check my eligibility
What is being tested?
The study tests if lenvatinib combined with everolimus (Arm A) or pembrolizumab (Arm B) is more effective than sunitinib alone (Arm C) in delaying disease progression in first-line treatment of advanced RCC. Participants will be randomly assigned to one of these treatments and monitored for progression-free survival using standard criteria.See study design
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, diarrhea, decreased appetite, weight loss from Lenvatinib; mouth sores and weakness from Everolimus; immune-related reactions such as lung inflammation or colitis from Pembrolizumab; and skin problems or digestive issues from Sunitinib.
CLEAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer diagnosis includes a clear-cell type.
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My kidney cancer is in an advanced stage.
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I am able to care for myself but may not be able to do active work.
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My bone marrow is working well.
CLEAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of randomization to the date of the first documentation of pd or date of death, whichever occurred first or up to data cutoff date 28 aug 2020 (up to approximately 46 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization to the date of the first documentation of pd or date of death, whichever occurred first or up to data cutoff date 28 aug 2020 (up to approximately 46 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS) by Independent Imaging Review (IIR)
Secondary outcome measures
Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib and Everolimus
HRQoL Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Score
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Score
+9 moreCLEAR Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Lenvatinib 20 mg plus Pembrolizumab 200 mgExperimental Treatment2 Interventions
Lenvatinib 20 mg administered orally, once daily, in each 21-day cycle plus pembrolizumab 200 mg administered intravenously (IV), every 3 weeks on Day 1 of each 21-day cycle.
Group II: Lenvatinib 18 mg plus Everolimus 5 mgExperimental Treatment2 Interventions
Lenvatinib 18 milligrams (mg) administered orally, once daily, plus everolimus 5 mg administered orally, once daily in each 21-day cycle.
Group III: Sunitinib 50 mgActive Control1 Intervention
Sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment in each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Lenvatinib
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
152,951 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,053,502 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or have it now.You have HIV.I am a male who hasn't had a vasectomy and agree to use a condom and spermicide.My kidney cancer is in an advanced stage.Your heart takes too long to recharge between beats.You have high levels of protein in your urine.Your cholesterol or triglyceride levels are too high when you haven't eaten for a while.Your diabetes is not well controlled, as shown by a high fasting glucose level.You currently have a disease where your immune system attacks your own body.You have at least one specific type of tumor that can be measured and meets certain criteria.I have had cancer within the last 2 years.I have not had radiation therapy in the last 21 days.I haven't taken any experimental drugs in the last 4 weeks.I currently have an infection.I still have side effects from recent major surgery.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have an immune system disorder or am on long-term steroids.My kidney cancer diagnosis includes a clear-cell type.I have a condition that affects how my body absorbs medication.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.My kidneys are working well.My blood clots normally.My liver is working well.I am able to care for myself but may not be able to do active work.I have an active Hepatitis B or C infection.I am not pregnant or breastfeeding.My cancer has spread to my brain or spinal cord.I am a woman able to have children and do not agree to use effective birth control.I have received an organ or tissue transplant from another person.I have not taken any drugs for kidney cancer that target blood vessel growth.I have a history of lung disease involving the tissue and space around the air sacs.My bone marrow is working well.I have not received a live vaccine in the last 30 days.I have not had major heart problems in the last year.My blood pressure is under control, with or without medication.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib 20 mg plus Pembrolizumab 200 mg
- Group 2: Sunitinib 50 mg
- Group 3: Lenvatinib 18 mg plus Everolimus 5 mg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please outline the possible side effects of lenvatinib?
"There is some data to support the efficacy of lenvatinib and it has undergone multiple rounds of testing, so it has been classified as a 3 in terms of safety."
Answered by AI
Can you list other research projects that have studied lenvatinib?
"lenvatinib was first studied in the year 2006 at University of Texas MD Anderson Cancer Center. So far there have been 928 completed studies. There are presently 1196 actively recruiting trials, with a large number of these studies based in Hamilton, New york."
Answered by AI
What are the primary illnesses that lenvatinib has been known to help?
"While lenvatinib is most frequently used to target malignant neoplasms, it has also been shown to be effective against unresectable melanoma, microsatellite instability high, and lung conditions."
Answered by AI
At how many institutions can patients participate in this research?
"In total, this clinical trial is running out of 55 hospitals, with three of them being St. Joseph's Healthcare Hamilton in Hamilton, New york, London Institute of Health Sciences in London, Illinois, and Sunnybrook Research Institute - University of Toronto in Toronto, Minnesota."
Answered by AI
Have similar experiments been conducted in the past?
"To date, there have been 1196 active clinical trials for lenvatinib conducted in 3265 cities across 66 countries. The first study, sponsored by Pfizer, was completed in 2006 and involved 64 participants. It reached Phase 2 of drug approval. Since then, 928 additional trials have been completed."
Answered by AI
Are we actively searching for participants for this experiment?
"Unfortunately, this study is no longer accepting patients. The posting for this trial was first made on October 13th, 2016 and was last updated over 4 years ago on July 1st, 2022. However, there are presently 2657 studies actively admitting participants with carcinoma and 1196 trials for lenvatinib actively admitting participants."
Answered by AI
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