Combination Therapy vs Standard Treatment for Kidney Cancer
(CLEAR Trial)

Recruiting in Palo Alto (17 mi)

+229 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eisai Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My kidney cancer is in an advanced stage.

Written informed consent

You have at least one specific type of tumor that can be measured and meets certain criteria.

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Exclusion 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.

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Treatment Details

Interventions

Everolimus (mTOR Inhibitor)
Lenvatinib (Tyrosine Kinase Inhibitor)
Pembrolizumab (PD-1 Inhibitor)
Sunitinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Everolimus is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Afinitor for: