Study on the Safety and Effects of Volrustomig and Axitinib for Patients with Advanced Kidney Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called Advanced Renal Cell Carcinoma, which is a form of kidney cancer that has spread beyond the kidney. The study is testing a new treatment combination to see how safe and effective it is for patients with this condition. The treatment involves a medication known as MEDI5752, which is a special type of protein designed to help the immune system fight cancer. It is being tested in combination with another medication called lenvatinib, which is taken as a capsule, or with axitinib, another cancer medication.

The purpose of the study is to evaluate the safety and potential benefits of these medications when used together. Participants will receive the treatment and be monitored for any side effects and how well the cancer responds to the treatment. The study will help determine the best dose of MEDI5752 to use in future research. The treatment with MEDI5752 is given through an infusion, which means it is administered directly into the bloodstream, while lenvatinib and axitinib are taken orally as capsules.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of the cancer. This includes various tests and assessments to ensure the treatment is working as intended and to identify any potential side effects. The study aims to provide valuable information that could lead to new treatment options for people with advanced kidney cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and medical history.

A written informed consent is required before any study-related procedures begin.

2 initial assessment

An initial assessment is conducted to evaluate overall health, including organ and marrow function.

A pregnancy test is required for female participants of childbearing potential.

3 treatment phase

The treatment involves the administration of lenvatinib and volrustomig.

Lenvatinib is taken orally in the form of hard capsules, available in 4 mg and 10 mg dosages.

Volrustomig is administered through an intravenous infusion.

4 monitoring and follow-up

Regular monitoring is conducted to assess safety and tolerability, including checking for any adverse events.

The effectiveness of the treatment is evaluated through various measures such as tumor response.

5 end of study

The study is estimated to conclude by September 27, 2027.

Final assessments are conducted to gather data on the long-term effects and outcomes of the treatment.

Who Can Join the Study?

Must be 18 years or older at the time of screening.
Must weigh more than 35 kilograms.
Must provide written informed consent before any study-related procedures.
Must have a confirmed diagnosis of advanced renal cell carcinoma (RCC) with a clear cell component. This means the cancer is in the kidneys and has specific cell characteristics.
Must not have received previous treatment for advanced RCC.
Must provide tumor material from a previous or new biopsy. This means a sample of the cancer tissue is needed for the study.
Must have an ECOG performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Must have at least one measurable lesion according to RECIST v1.1. This means there must be a tumor that can be measured to see if it changes during the study.
Must have a life expectancy of at least 12 weeks.
Must have adequate organ and marrow function without recent transfusions or growth factor support. This means the organs and bone marrow are working well enough to participate in the study.
Female subjects of childbearing potential must have a negative pregnancy test at screening and before each treatment. If sexually active with a nonsterilized male partner, they must use a highly effective method of birth control during the study and for a specified time after the last dose of the study drugs.
Female subjects must not breastfeed or donate/retrieve eggs for their own use during the study and for a specified time after the last dose of the study drugs.
Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide during the study and for a specified time after the last dose of the study drugs.

Who Cannot Join the Study?

Patients who have a different type of cancer than Advanced Renal Cell Carcinoma cannot participate. This is a specific type of kidney cancer.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to safely take the study medications, such as MEDI5752 combined with lenvatinib or axitinib, cannot participate. These are specific drugs used in the study.
Patients who are part of a vulnerable population that the study cannot safely include will not be able to participate. This means people who might be at higher risk of harm from the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Ilairwcd Ctgulv Dmxrfuuglaimusldy	L'hospitalet De Llobregat	Spain
Pwip Tasgy Hrgrbdnw Uhszrcyzlkpa	Sabadell	Spain
Hllgfbcz Dp Lw Sozaa Cplb I Sfnk Phd	Barcelona	Spain
Hczegyfy Uuteigkbosyjx Hpxvdskb Trpro y Pbhkjg Iofvydgx Cjamke dymswcgyzaegpvadl (gjqw	Badalona	Spain
Hlfzvvon Vzsf dxwzextc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.10.2020
Spain	Not recruiting	15.10.2020

Trial locations

Investigated drugs:

MEDI5752 is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested to see how safe and tolerable it is for patients with advanced renal cell carcinoma, a type of kidney cancer. Researchers are also looking at how well it works in shrinking tumors when used in combination with other treatments.

Axitinib is a medication used to treat advanced kidney cancer. It works by blocking certain proteins that help cancer cells grow and spread. In this study, axitinib is being combined with MEDI5752 to see if the combination is more effective in treating renal cell carcinoma.

Lenvatinib is another medication used to treat certain types of cancer, including kidney cancer. It works by interfering with the growth of cancer cells and slowing down their spread. In this trial, lenvatinib is being combined with MEDI5752 to evaluate the safety and effectiveness of this combination in treating advanced renal cell carcinoma.

Investigated diseases:

Renal cell carcinoma

Advanced Renal Cell Carcinoma – This is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is considered advanced when it has spread beyond the kidney to other parts of the body. The disease often progresses by forming tumors that can grow and invade nearby tissues or spread to distant organs. Symptoms may include blood in the urine, pain in the side or back, and a lump in the abdomen. As the disease advances, it can lead to fatigue, weight loss, and fever. The progression can vary, with some cases remaining stable for a period while others may progress more rapidly.

Trial ID:

2023-509604-15-00

NCT ID:

NCT04522323

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Volrustomig and Axitinib for Patients with Advanced Kidney Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?