Not recruiting

Study of Pembrolizumab and Epacadostat vs Standard Treatment for Patients with Advanced or Metastatic Kidney Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of kidney cancer known as locally advanced or metastatic renal cell carcinoma. The study is investigating the effectiveness and safety of a new treatment combination compared to standard treatments. The new treatment being tested includes pembrolizumab, also known by its code name MK-3475, and epacadostat. The standard treatments being compared are sunitinib and pazopanib, which are commonly used medications for this type of cancer.

The purpose of the study is to evaluate how well the new treatment combination works and how safe it is for patients. Participants in the study will receive either the new treatment or one of the standard treatments. The study will monitor the response of the cancer to the treatment and any side effects that may occur. The new treatment involves the use of pembrolizumab, which is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. Epacadostat is taken orally, which means it is swallowed in pill form. The standard treatments, sunitinib and pazopanib, are also taken orally.

The study will take place over a period of time, during which participants will be regularly monitored by healthcare professionals. The goal is to determine if the new treatment combination can provide better outcomes for patients with this type of kidney cancer compared to the standard treatments. Participants will be closely observed for any changes in their condition and any side effects they may experience during the course of the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, confirmation of the diagnosis of locally advanced or metastatic renal cell carcinoma is required. This includes a clear-cell component, with or without sarcomatoid features.
No prior systemic therapy for the condition should have been received. A measurable disease based on specific criteria is necessary.
A tumor tissue sample, either archival or newly obtained, is required for the study.
Step 2
Initial assessment
An initial assessment will be conducted to ensure adequate organ function and a performance status of at least 70% on the Karnofsky scale.
Step 3
Treatment allocation
Participants will be randomly assigned to receive either the combination of pembrolizumab and epacadostat or the standard of care, which includes either sunitinib or pazopanib.
Step 4
Treatment administration
For those receiving pembrolizumab, it will be administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.
Participants receiving sunitinib or pazopanib will take these medications orally. The dosage and frequency will be specified according to the standard treatment guidelines.
Step 5
Monitoring and follow-up
Regular monitoring will occur to assess the objective response rate and to evaluate the safety and tolerability of the treatments.
Participants will be observed for any adverse events, and adjustments to the treatment may be made if necessary.
Step 6
Completion of the study
The study is estimated to conclude by the end of 2024. Participants will undergo a final assessment to determine the overall response to the treatment.

Who can join the trial?

7 criteria

The patient must have a confirmed diagnosis of a type of kidney cancer called locally advanced or metastatic renal cell carcinoma with a clear-cell component. This means the cancer has spread beyond the kidney.
The patient must not have received any previous treatments that affect the whole body for their kidney cancer.
The patient must have a disease that can be measured using specific criteria called RECIST v1.1, which is a way to assess how the cancer responds to treatment.
The patient must provide a sample of their tumor tissue, either from a previous collection or a new biopsy, which is a procedure to remove a small piece of the tumor for testing.
The patient must have a Karnofsky performance status of 70% or higher. This is a scale from 0 to 100 that measures the patient's ability to perform daily activities, with higher numbers indicating better function.
The patient must have organs that are working well enough according to specific criteria set by the study.
Both male and female patients are eligible to participate.

Who cannot join the trial?

6 criteria

Patients with other types of cancer besides locally advanced/metastatic renal cell carcinoma cannot participate. This means the study is only for those with a specific type of kidney cancer that has spread or is advanced.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible to participate.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have had certain treatments or medications recently that might interfere with the study cannot participate.
Patients with certain medical conditions that could affect the study results or their safety cannot participate.

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Verified sites

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Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain

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Investigated drugs

Pembrolizumab
is a medication used in this trial to help the immune system detect and fight cancer cells. It is often used in various types of cancer treatments and works by blocking a specific protein that prevents the immune system from attacking cancer cells.
Epacadostat
is a medication that is being studied for its potential to enhance the effects of pembrolizumab. It works by inhibiting an enzyme that can suppress the immune system, thereby potentially allowing the immune system to better target and destroy cancer cells.
Sunitinib
is a standard treatment option for renal cell carcinoma. It works by blocking certain proteins that promote the growth of cancer cells and blood vessels that supply tumors, thereby slowing down or stopping the growth of cancer.
Pazopanib
is another standard treatment for renal cell carcinoma. Similar to sunitinib, it targets proteins involved in the growth of cancer cells and blood vessels, helping to slow or stop the progression of the disease.

What is already known about the treatment

Pembrolizumab
This medication is administered intravenously and is currently used in clinical trials for treating locally advanced or metastatic renal cell carcinoma. It is a well-established immunotherapy drug in medical literature, primarily used for various types of cancer. Pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody.
Epacadostat
Administered orally, this medication is being studied in combination with pembrolizumab for its potential to treat locally advanced or metastatic renal cell carcinoma. It is still under investigation in clinical trials and not yet widely used in standard medical practice. Epacadostat inhibits the IDO1 enzyme, which can suppress the immune response against cancer cells, thereby enhancing the effects of immunotherapy. It is classified as an enzyme inhibitor.
Sunitinib
This oral medication is a standard treatment option for locally advanced or metastatic renal cell carcinoma. It is well-documented in medical literature and widely used in clinical practice. Sunitinib works by inhibiting multiple receptor tyrosine kinases, which are involved in tumor growth and angiogenesis. It is classified as a tyrosine kinase inhibitor.
Pazopanib
Administered orally, this medication is another standard treatment for locally advanced or metastatic renal cell carcinoma. It is well-established in medical literature and commonly used in clinical settings. Pazopanib functions by inhibiting several tyrosine kinases, which play a role in tumor growth and blood vessel formation. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Renal Cell Carcinoma – Renal cell carcinoma is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is the most common type of kidney cancer in adults. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, indicating it has spread to other parts of the body. As the cancer progresses, it may cause symptoms such as blood in the urine, a lump in the abdomen, or persistent pain in the side. The progression of the disease can vary, with some cases remaining stable for long periods, while others may grow and spread more rapidly.