Combination Therapy vs Standard Treatment for Kidney Cancer
(CLEAR Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received any systemic anticancer therapy for RCC or investigational drugs recently. It's best to discuss your current medications with the trial team to ensure they don't conflict with the study requirements.
What data supports the effectiveness of the drug combination therapy for kidney cancer?
Is the combination therapy of lenvatinib and pembrolizumab or everolimus safe for treating kidney cancer?
The combination of lenvatinib with pembrolizumab or everolimus has been studied for safety in treating advanced kidney cancer. Common adverse reactions (side effects) have been identified, and strategies for managing these side effects are available, indicating that while there are risks, they are known and can be managed.23467
What makes this drug combination unique for kidney cancer?
This drug combination is unique because it combines lenvatinib and everolimus, which are the first successful pairing of tyrosine kinase and mTOR inhibitors for kidney cancer after other treatments have failed. It offers a new option for patients who have developed resistance to standard therapies that target blood vessel growth in tumors.12348
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).
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either lenvatinib in combination with everolimus or pembrolizumab, or sunitinib alone as first-line treatment for advanced renal cell carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Everolimus
- Lenvatinib
- Pembrolizumab
- Sunitinib
Everolimus is already approved in United States, European Union for the following indications:
- Advanced renal cell carcinoma
- Subependymal giant cell astrocytoma
- Progressive neuroendocrine tumors of pancreatic origin
- Advanced hormone receptor-positive, HER2-negative breast cancer
- Tuberous sclerosis complex-associated partial-onset seizures
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
- Prevention of organ rejection in kidney transplant patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eisai Inc.
Lead Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University