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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

Must not have

Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis

Prior radiation therapy within 21 days prior to start of study treatment

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

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or have it now.

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I have not had radiation therapy in the last 21 days.

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I currently have an infection.

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I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.

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I have an immune system disorder or am on long-term steroids.

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I have a condition that affects how my body absorbs medication.

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I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

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I have an active Hepatitis B or C infection.

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I am a male who hasn't had a vasectomy and agree to use a condom and spermicide.

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I am not pregnant or breastfeeding.

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My cancer has spread to my brain or spinal cord.

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I am a woman able to have children and do not agree to use effective birth control.

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I have received an organ or tissue transplant from another person.

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I have not taken any drugs for kidney cancer that target blood vessel growth.

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I have a history of lung disease involving the tissue and space around the air sacs.

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I have not received a live vaccine in the last 30 days.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS) by Independent Imaging Review (IIR)

Secondary study objectives

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 more

Awards & Highlights

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.

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