Study of Nivolumab and Ipilimumab or Drug Combination for Patients with Metastatic Kidney Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic kidney cancer, which is a type of cancer that has spread from the kidney to other parts of the body. The study will explore the effectiveness of two medications, nivolumab and ipilimumab, either used alone or in combination, as well as a group of drugs known as VEGFR tyrosine kinase inhibitors (tKi), which includes medications like sunitinib and pazopanib. These treatments are given to patients who have not received prior systemic therapy for their cancer.

The purpose of the study is to evaluate how well these treatments work in different molecular subgroups of kidney cancer. Participants will receive one of the treatments based on their specific molecular group, which is determined by analyzing tumor samples. The study will monitor the response to treatment, including whether the cancer shrinks or disappears, and how long patients live without the cancer getting worse. The treatments are administered through an intravenous route, meaning they are given directly into a vein.

Throughout the study, participants will be regularly assessed by investigators to track their response to the treatment. This includes checking for any changes in the size of the cancer and monitoring overall health. The study aims to provide valuable information on the effectiveness of these treatments for metastatic kidney cancer, potentially leading to improved treatment options for patients in the future.

1 joining the trial

Upon joining the trial, the patient will be assigned to a treatment group based on their specific molecular group. This assignment is determined by analyzing tumor samples provided by the patient.

2 treatment initiation

The patient will begin treatment with either nivolumab alone, nivolumab combined with ipilimumab, or a different type of medication known as a tyrosine kinase inhibitor (TKI), which could be sunitinib or pazopanib. The specific treatment will depend on the patient’s molecular group.

3 medication administration

The medications nivolumab and ipilimumab are administered through an intravenous (IV) infusion. This means the medication is given directly into a vein. The frequency and dosage will be determined by the healthcare team based on the treatment plan.

4 monitoring and assessments

Throughout the trial, the patient’s response to the treatment will be closely monitored. This includes regular medical assessments and imaging tests, such as CT or MRI scans, to evaluate the size of the tumors and check for any changes.

5 evaluation of response

The main goal is to assess the patient’s overall response to the treatment. This involves determining whether the tumors have shrunk or disappeared, which is referred to as a complete or partial response.

6 end of treatment

The duration of the treatment will vary depending on the patient’s response and any side effects experienced. The treatment may continue until the end of the study or until it is no longer beneficial for the patient.

7 follow-up

After the treatment ends, the patient will have follow-up visits to monitor their health and any long-term effects of the treatment. These visits are important to ensure the patient’s well-being and to gather additional data for the study.

Who Can Join the Study?

Must have a confirmed diagnosis of kidney cancer with a clear-cell component. This means the cancer cells have a specific appearance under a microscope.
Must have metastatic kidney cancer, which means the cancer has spread to other parts of the body.
Must not have received any previous treatment for metastatic kidney cancer. However, if you had treatment more than one year ago and the cancer returned, you may still be eligible.
Must have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how well you can perform daily activities. A score of 0 means fully active, while 2 means you are up and about more than half the day.
Must have a measurable disease according to specific criteria used by doctors to assess cancer size and spread.
Must provide frozen or fresh tumor samples for laboratory analysis. These samples help determine the specific type of kidney cancer. Note: Samples from fine needle aspiration or bone metastases are not acceptable.
Must have formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for further analysis. This is a method of preserving tissue samples for study.
The specific molecular group of your cancer must be identified before you can be randomly assigned to a treatment group in the study.
Must be aged 18 years or older.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with any other type of cancer besides kidney cancer cannot participate.
Patients who have had another cancer in the past, unless it was successfully treated and has not come back for at least 5 years, cannot participate.
Patients with serious heart problems, such as a recent heart attack or heart failure, cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with active infections that require treatment with antibiotics cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received another experimental treatment within the last 4 weeks cannot participate.
Patients with known allergies to the study drugs cannot participate.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
Patients with brain metastases, which are cancer cells that have spread to the brain, cannot participate unless they have been treated and are stable.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Paris – Hôpital Cochin	Paris	France
Hôpital Européen Georges-Pompidou	Paris	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hospital Foch	Suresnes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
CHU DeBordeaux	Bordeaux	France
Irneuglb dy Catfkkkvysyo df Ggjd	Nimes	France
Chlaum Hzbuwvfvjlq Rjppmfil Uymzpmhgoawvx Dk Tqhzb	Tours	France
Ithnzpis Mdgvankkpj Mtqwvfemia	Paris	France
Hxcuewx Hkjol Mefrtb &pgrlkd 1 rvx Gmlwlow Eblbft	Creteil	France
Itkfhdie Pkrphdljpkxorig Cfgbdl Csrzbu	Marseille	France
Cfchrz Oyjmv Lcwaxay	Lille	France
Hmgcbgrl Uyidelqsawmmja Sqsvyskahr &yevbih Hwuogmx dm Hnihvghvngc	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	31.05.2017

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used to treat patients with metastatic kidney cancer, either on its own or in combination with another medication.

Ipilimumab is another immune checkpoint inhibitor. It helps boost the immune system’s response against cancer cells. In this trial, it is used in combination with nivolumab to enhance the treatment’s effectiveness for patients with metastatic kidney cancer.

Sunitinib is a medication that targets specific proteins in cancer cells, which helps stop the cancer from growing and spreading. It is used in this trial as an alternative treatment option for patients with metastatic kidney cancer.

Pazopanib is a medication that works by blocking certain proteins that cancer cells need to grow. It is used in this trial as another treatment option for patients with metastatic kidney cancer, similar to sunitinib.

Investigated diseases:

Renal cancer

Kidney Cancer – Kidney cancer is a type of cancer that begins in the kidneys, which are two bean-shaped organs located behind the abdominal organs. The most common type of kidney cancer in adults is renal cell carcinoma, which usually starts in the lining of tiny tubes in the kidney. As the disease progresses, cancer cells can grow and form a mass or tumor, potentially spreading to other parts of the body. Symptoms may not appear in the early stages, but as the tumor grows, it can cause blood in the urine, persistent pain in the back or side, and unexplained weight loss. The progression of kidney cancer can vary, with some tumors growing slowly over time, while others may be more aggressive.

Trial ID:

2024-520045-23-00

NCT ID:

NCT02960906

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Nivolumab and Ipilimumab or Drug Combination for Patients with Metastatic Kidney Cancer

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