Study on Pausing Treatment with Pembrolizumab and Axitinib in Patients with Metastatic Kidney Cancer at Good or Intermediate Risk

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as metastatic renal cell carcinoma (mRCC). This cancer has spread beyond the kidney and is being studied in patients who have a good or only one adverse risk factor. The study involves two treatments: Inlyta, which contains the active substance axitinib, and Keytruda, which contains pembrolizumab. Inlyta is taken as a tablet, while Keytruda is given as an infusion into a vein. These treatments are part of a group of medications called PD-1/PD-L1 immune checkpoint inhibitors and VEGFR-Tyrosine Kinase Inhibitors (TKI), which help the immune system fight cancer and block signals that help cancer cells grow.

The purpose of the study is to see if taking a break from these treatments is as effective as continuing them for patients who have responded well to the treatment after about a year. Participants in the study will be randomly assigned to either pause or continue their treatment. The study will monitor the participants’ health and cancer status over time to see if the cancer stays under control without the treatment. The study will last for up to 24 months, and participants will have regular check-ups and assessments to track their progress.

Throughout the study, researchers will look at various aspects, such as how many participants do not experience cancer progression, the side effects of the treatments, and the overall quality of life of the participants. The study aims to provide valuable information on whether a treatment pause can be a safe and effective option for patients with mRCC who have responded well to initial treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

A signed informed consent form is required to participate.

2 initial treatment phase

The initial treatment involves a combination of two medications: axitinib and pembrolizumab.

Axitinib is taken orally in the form of Inlyta 5 mg film-coated tablets.

Pembrolizumab is administered intravenously as KEYTRUDA 25 mg/mL concentrate for solution for infusion.

This phase continues until an objective response is achieved, typically between the end of the 11th month and the end of the 13th month of treatment.

3 randomization

After achieving an objective response, participants are randomly assigned to either continue treatment or pause treatment.

The decision is based on the study’s aim to assess the non-inferiority of treatment pause compared to treatment continuation.

4 treatment continuation or pause

Participants in the continuation group will keep receiving the combination of axitinib and pembrolizumab as previously described.

Participants in the pause group will stop the treatment temporarily to evaluate the effects of a treatment break.

5 monitoring and follow-up

Participants are monitored for up to 12 months after randomization to assess disease progression and any adverse events.

Quality of life and psychological well-being are evaluated using specific questionnaires.

The study also measures overall survival and progression-free survival over a two-year period.

6 end of study

The study is estimated to conclude by January 23, 2027.

Final assessments will be conducted to gather comprehensive data on the outcomes of treatment continuation versus pause.

Who Can Join the Study?

Must be 18 years or older at the time of signing the consent form.
Must have a Karnofsky Performance Status (KPS) of 70% or higher. This is a scale that measures the ability to perform daily activities.
Must have a measurable disease as determined by a CT scan at the start of the first treatment.
Must have adequate organ function.
Females who can have children must use highly effective birth control methods and continue using them for 5 months after the last treatment.
Sexually active males must agree to use condoms and continue using them for 5 months after the last treatment.
Must be willing and able to follow study procedures.
Must be part of a social security system or have similar benefits.
Must sign an informed consent form.
Must have a confirmed diagnosis of renal cell carcinoma (RCC) with a clear-cell component, which may include a sarcomatoid feature.
Must have advanced or metastatic RCC, meaning the cancer has spread and cannot be cured with surgery or radiation.
Must have a good or intermediate risk with only one adverse prognostic factor according to the International Metastatic RCC Database Consortium (IMDC) criteria.
Must have had prior first-line therapy for metastatic RCC with a combination of PD-1/PD-L1 ICI and VEGFR-TKI.
Must be currently receiving first-line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI, with no treatment breaks longer than 6 weeks for PD-1/PD-L1 ICI and 2 weeks in the last 3 months for VEGFR-TKI.
Must have shown an objective response (complete or partial) between the end of the 11th month and the end of the 13th month of combination treatment.
A CT scan from the start of this treatment must be available.

Who Cannot Join the Study?

Patients who have not been diagnosed with metastatic renal cell carcinoma (mRCC). This is a type of kidney cancer that has spread to other parts of the body.
Patients who do not have a good or only one adverse prognostic factor intermediate risk according to the IMDC score. The IMDC score is a system used to predict the outcome of kidney cancer treatment.
Patients who have not achieved an objective response between the end of the 11th month and the end of the 13th month of treatment. An objective response means that the cancer has shrunk or disappeared after treatment.
Patients who are not within the specified age range for the study.
Patients who are not male or female, as the study includes both genders.
Patients who are part of a vulnerable population that is not selected for this study.

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
Centr Georges Francois Leclerc	Dijon	France
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Polyclinique De Limoges	Limoges	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Icbfdxml Rqsjfxax Ds Cqxxec Dk Mtpkjfjemwj	Montpellier	France
Crbbvv Lwko Bdtqxl	Lyon	France
Cspkaa Hqyayarsodb Eq Urbszbtjfuyqm Dn Lyqdyvk	Limoges	France
Ckzhuk Hschlqzonnd Rruvuvqo Unayxptkscdec Dm Tqoet	Tours	France
Ibztrnlb do Cpwchwwhowgd Hpmzrobicym Ubuckiwfqhsza di Sdmjg Edrqpcp (asoxmhc	Saint Priest En Jarez	France
Iscnlqxn Pffxjtlybuzcjln Cmcqef Ckkstw	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	23.01.2023

Trial locations

Investigated drugs:

PD-1/PD-L1 Immune Checkpoint Inhibitors are medications that help the immune system recognize and attack cancer cells. They work by blocking proteins that prevent the immune system from attacking the cancer, allowing the body’s natural defenses to target and destroy cancer cells more effectively.

VEGFR-Tyrosine Kinase Inhibitors are drugs that block specific proteins involved in the growth of blood vessels that supply nutrients to tumors. By inhibiting these proteins, these medications can help slow down or stop the growth of cancer by cutting off its blood supply.

Investigated diseases:

Metastatic renal cell carcinoma

Metastatic Renal Cell Carcinoma (mRCC) – This is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It often begins in the lining of the small tubes in the kidney and can progress to affect organs such as the lungs, bones, or liver. The disease is characterized by the growth of cancerous cells that can form tumors in the kidney and metastasize to distant sites. The progression of mRCC can vary, with some patients experiencing slow growth of tumors, while others may have more aggressive disease. Factors such as genetic mutations and the body’s immune response can influence how the disease develops. The condition is often monitored through imaging tests to assess the spread and growth of tumors.

Trial ID:

2024-514644-93-00

Protocol code:

CHUBX 2021/08

NCT ID:

NCT05219318

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pausing Treatment with Pembrolizumab and Axitinib in Patients with Metastatic Kidney Cancer at Good or Intermediate Risk

What is this study about?

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