Active not recruitingPHASE3INTERVENTIONAL

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

This important study is for people with advanced kidney cancer, also known as renal cell carcinoma. We want to find out if new drug combinations could be better than a current standard treatment. Patients will receive either Sunitinib, which is a common treatment, or one of two new combinations: Lenvatinib with Everolimus, or Lenvatinib with Pembrolizumab. Doctors will carefully monitor how long it takes for the cancer to show signs of growing again, using regular scans. The main goal is to see if either of the new combinations can stop the cancer from getting worse for a longer period compared to Sunitinib alone. This is a large study in its final stages of testing, aiming to improve future treatments for this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eisai Inc.

Enrolment target

1,069

Start

13 Oct 2016

Estimated completion

31 Mar 2027

Renal Cell Carcinoma

Results

Results from this study

Posted September 2021

Results have been published for this study.

Primary outcome

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

PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.

Full results on the registry

What is this study about?

This study is looking into better ways to treat advanced kidney cancer, specifically a type called renal cell carcinoma. When cancer is advanced, it means it has spread from where it first developed to other parts of the body.

Currently, one of the treatments for advanced kidney cancer is a drug called Sunitinib. In this study, we are comparing Sunitinib with two newer combination treatments. One combination involves two drugs called Lenvatinib and Everolimus, and the other uses Lenvatinib and Pembrolizumab. We want to see if either of these combinations works better at controlling the cancer.

The main thing doctors will be looking at is called 'progression-free survival'. This means measuring how long a person can live without their cancer growing or getting worse. By comparing the new combinations with Sunitinib, we hope to find out if they can keep the cancer under control for a longer time, offering a new and potentially more effective treatment option for patients in the future.

Key takeaways

Compares standard kidney cancer treatment with two new combinations.
Aims to find treatments that stop cancer growth for longer.
Participation involves regular hospital visits, blood tests, and scans.
Treatment arm is chosen randomly, not by patient.
Close monitoring for effectiveness and side effects.
You can leave the study at any time.

Who may be eligible?

To join this study, doctors first need to confirm you have kidney cancer with a specific type of cell called 'clear-cell component' and that it is considered 'advanced'. For doctors to track how well treatment is working, you need to have at least one measurable area of cancer, such as a lymph node that is at least 1.5 cm across, or another area of cancer that is at least 1 cm long. These areas must be suitable for regular scans like CT or MRI to check for changes.

Your general health is also important. You should be able to carry out most of your daily activities without much difficulty (this is measured by something called a Karnofsky Performance Status of 70% or more). Your blood pressure should be well-controlled with or without medication, and your kidneys, a part of your blood (bone marrow), and your blood's ability to clot should be working well. This is checked through blood tests.

Lastly, you must be at least 18 years old to take part in this study. The study is open to both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced kidney cancer (renal cell carcinoma) with a clear-cell component?
Do I have at least one measurable area of cancer that can be scanned?
Am I generally well enough to do most of my daily activities?
Is my blood pressure well-controlled?
Are my kidneys, blood cell counts, and blood clotting working properly?
Am I 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to receive one of the three treatments: Sunitinib, Lenvatinib with Everolimus, or Lenvatinib with Pembrolizumab. You won't choose which treatment you get; it will be decided randomly, like flipping a coin, to ensure a fair comparison. The treatments are given as pills you take by mouth and/or infusions (drips) into your vein, depending on the specific drugs.

You will have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI) to see how the cancer is responding to the treatment. These scans are crucial for doctors to measure if the cancer is shrinking, staying the same, or growing. You'll also be monitored closely for any side effects from the medication. The total duration of your participation will depend on how your cancer responds to the treatment and how you tolerate it. Follow-up appointments will continue even after treatment finishes to monitor your long-term health.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially more effective combination treatment for your kidney cancer that isn't yet widely available. You will also be closely monitored by a team of medical professionals. However, like all medical treatments, there are potential risks, including known and unknown side effects from the study medications. These side effects can vary from mild to severe, and the medical team will discuss these with you in detail. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (183)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Stanford School of Medicine
Verified postcode
Stanford, United States
Boca Raton Community Hospital
Verified postcode
Boca Raton, United States
Florida Cancer Specialists
Verified postcode
Fort Myers, United States
University of Miami
Verified postcode
Miami, United States
Mount Sinai Medical Center
Verified postcode
Miami Beach, United States
Florida Hospital Cancer Institute
Verified postcode
Orlando, United States
Florida Cancer Specialists ( North Region)
Verified postcode
St. Petersburg, United States
Florida Cancer Specialists
Verified postcode
West Palm Beach, United States
Joliet Oncology - Hematology Associates
Verified postcode
Joliet, United States
Healthcare Research Network III, LLC
Verified postcode
Tinley Park, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
Verified postcode
Overland Park, United States
Cotton-Oneil Clinical Research Center
Verified postcode
Topeka, United States

Common questions

What is 'advanced' kidney cancer?

Advanced kidney cancer means the cancer has spread from the kidney to other parts of your body.

What does 'progression-free survival' mean?

It's how long you live without your cancer growing or getting worse, according to doctors' scans.

Will I get to choose my treatment?

No, the treatment you receive is chosen randomly, similar to drawing straws, to ensure a fair comparison between the options.

How long will I be in the study?

Your time in the study depends on how your body responds to the treatment and how you tolerate it. You'll be closely monitored throughout.

What if I feel unwell during the study?

The study team will monitor you closely for any side effects. You should always tell them about any new or worsening symptoms immediately.