Study of Axitinib and Pembrolizumab for Patients with Advanced or Metastatic Papillary Renal Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as papillary renal cell carcinoma (PRCC), which can be locally advanced or has spread to other parts of the body. The study is investigating the effectiveness of two medications: axitinib and pembrolizumab. Pembrolizumab is also known by other names such as MK-3475 and is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. Axitinib is taken orally, which means it is consumed by mouth.

The purpose of this study is to evaluate how well the combination of axitinib and pembrolizumab works compared to axitinib alone in treating patients with this type of kidney cancer. Participants in the study will receive either the combination of both medications or axitinib by itself. The study will monitor the response to the treatment over a period of time to see which approach is more effective. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, participants will have regular visits to the clinic for treatment and monitoring. This will include receiving the medication, having blood tests, and undergoing other necessary procedures to ensure their safety and to track the progress of the treatment. The study aims to provide valuable information on the best treatment options for patients with papillary renal cell carcinoma.

1 joining the study

Upon joining the study, the patient must have signed and dated an approved informed consent form. This confirms understanding and agreement to participate in the study.

The patient must meet specific criteria, including being 18 years or older, having a confirmed diagnosis of locally advanced or metastatic papillary renal cell carcinoma (PRCC), and having no prior systemic treatment for renal cancer.

2 initial assessment

An initial assessment is conducted to ensure the patient meets all inclusion criteria. This includes evaluating the patient’s performance status, confirming adequate bone marrow, liver, and kidney function, and ensuring no significant proteinuria is present.

3 treatment phase

The treatment phase involves administering two medications: pembrolizumab and axitinib.

Pembrolizumab is given as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

Axitinib is taken orally. The dosage and frequency are also specified in the study protocol.

The treatment aims to evaluate the effectiveness of the combination of these medications in treating PRCC.

4 monitoring and follow-up

Throughout the study, the patient’s response to treatment is closely monitored. This includes regular visits for assessments and laboratory tests.

The primary goal is to measure the objective response rate (ORR), which indicates how well the cancer responds to the treatment.

Secondary goals include evaluating the duration of response, progression-free survival, overall survival, and safety of the treatment.

5 end of study

The study is estimated to conclude by May 31, 2027. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Must be at least 18 years old on the day of signing the consent form.
Must be willing and able to attend scheduled visits, follow treatment plans, and undergo tests and procedures required by the study.
If capable of having children, must agree to use effective birth control or avoid heterosexual activity during the study and for a specified time after the last dose of treatment.
Must sign and date an approved consent form before any study-specific procedures or assessments.
Must have a type of kidney cancer called type 2 papillary renal cell carcinoma (PRCC) that is either spread to other parts of the body or cannot be removed by surgery. This must be confirmed by a central review of tissue samples.
Must not have received any previous treatment for kidney cancer, including chemotherapy, immunotherapy, or other drugs.
Must have at least one area of cancer that can be measured according to specific guidelines.
Must have a good general health status, as measured by a specific scale called the Eastern Cooperative Oncology Group (ECOG) Performance Status, with a score of 0 or 1.
If previously received radiation therapy, must have stopped it at least 3 weeks before starting the study treatment and have recovered from any side effects.
Must have adequate functioning of bone marrow, liver, and kidneys, as shown by specific blood test results.
Must not have significant levels of protein in the urine, as confirmed by a urine test.
Must have medical or health insurance coverage.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have already received treatment for their cancer.
Patients who have serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients who have allergies to the study medications.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Ciiteu Lfxf Bdhmoh	Lyon	France
Bcgcnypa Ugxgoxwmkw Hensnedg Cltiad	Besançon	France
Cacwzd Hlyarrtnuxt Rtwnjyeh Uluueyzfyffrt Dy Tnpqy	Tours	France
Ieuvbouj Pjicdqtadptgomp Cxdjrq Cblqrx	Marseille	France
Hwiqnkzw Umdgnodvztnten Sqihxdttvv &jwwwka Hvwmsrv dr Hqxshpfrnzr	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2022

Trial locations

Investigated drugs:

Axitinib is a medication used to treat certain types of kidney cancer. In this clinical trial, it is being tested to see how well it works for patients with advanced or metastatic papillary renal cell carcinoma. Axitinib works by blocking certain proteins that help cancer cells grow, which may slow down or stop the growth of the cancer.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system fight cancer. It is being tested in combination with axitinib to see if it improves treatment outcomes for patients with advanced or metastatic papillary renal cell carcinoma. Pembrolizumab works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy the cancer.

Investigated diseases:

Metastatic renal cell carcinoma

Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) – This is a type of kidney cancer that originates in the renal tubules and is characterized by the formation of small, finger-like projections. It is classified as either type 1 or type 2, with type 2 being more aggressive. In its locally advanced stage, the cancer has spread beyond the kidney to nearby tissues or lymph nodes. When metastatic, it has spread to distant parts of the body, such as the lungs or bones. The disease progresses as cancer cells continue to grow and invade other tissues, potentially leading to various symptoms depending on the organs affected. The progression can vary significantly among individuals, influenced by factors such as the cancer’s genetic characteristics and the patient’s overall health.

Trial ID:

2024-513986-38-00

Protocol code:

ET21-023

NCT ID:

NCT05096390

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Axitinib and Pembrolizumab for Patients with Advanced or Metastatic Papillary Renal Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?