Active not recruitingPHASE2INTERVENTIONAL

Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer

This study is for people with a certain type of kidney cancer called clear cell renal cell carcinoma, which can be removed with surgery but is considered at intermediate to high risk. Researchers are testing three different combinations of immunotherapy medicines (nivolumab, ipilimumab, and relatlimab) given for a short period before surgery. The main goal is to see how well these medicines shrink the tumour before the operation. Patients will be randomly assigned to one of the three treatment groups. This is a Phase II trial, meaning it's still in the early stages of testing these specific combinations. Regular check-ups will continue for up to five years after surgery.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

The Netherlands Cancer Institute

Enrolment target

Start

28 Apr 2022

Estimated completion

01 Apr 2029

Renal Cell Carcinoma

What is this study about?

This study, called NESCIO, is a clinical trial exploring new ways to treat a specific type of kidney cancer known as clear cell renal cell carcinoma. This type of cancer is often treated with surgery, but for some people, there might be a higher risk of the cancer coming back. The study is investigating if giving a short course of immunotherapy medicines before surgery could be helpful.

Immunotherapy works by helping your own immune system fight cancer cells. The study is comparing three different combinations of these medicines: nivolumab by itself, or nivolumab combined with either ipilimumab or relatlimab. Doctors want to see if these treatments can shrink the tumour before surgery, which might make the surgery more successful or reduce the chances of the cancer returning. This type of treatment given before surgery is called 'neoadjuvant therapy'.

Participants in the study will be randomly assigned to one of the three treatment groups, like drawing names from a hat. This helps ensure the results are fair and reliable. The study will look closely at how the tumours respond to the treatment before surgery, and then continue to follow patients for several years to see how they are doing overall.

Key takeaways

Tests new immunotherapy combinations for kidney cancer before surgery.
Aims to see if treatment can shrink tumours before surgery.
Participants are randomly assigned to one of three treatment groups.
Study involves blood tests, scans, and doctor visits over several years.
This is an early-stage (Phase II) study, exploring new options.

Who may be eligible?

To join this study, you need to be at least 18 years old and generally healthy enough for everyday activities. You must have clear cell renal cell carcinoma that can be removed with surgery and hasn't spread to other parts of your body. Also, your medical team will need to confirm that your cancer falls into a specific risk category.

There are also some things that would prevent you from joining. For example, if you've had certain types of immunotherapy in the past, or if you're taking medicines that suppress your immune system. You'll also need to have healthy results from certain blood tests. If you're a woman who could become pregnant, you'll need to use reliable birth control during and after the study and have a negative pregnancy test before starting treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have clear cell kidney cancer that can be removed by surgery and hasn't spread?
Are you generally feeling well and able to do your usual activities?
Have you not had immunotherapy for cancer in the past and are not on immune-suppressing medications?
Are your routine blood test results (like kidney and liver function) within a healthy range?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo some screening tests, which include blood tests and possibly a tumour biopsy. If you're eligible, you'd be randomly assigned to one of three treatment groups. You would receive two cycles of immunotherapy treatment, given every three weeks into a vein. This treatment would happen before your planned surgery, which is typically around week 7 of the study.

After surgery, you'll have regular check-ups. This includes a CT scan around week 12, and then physical exams and blood tests every three months for up to two years. After that, monitoring will continue according to standard medical practice for up to five years after your surgery. Throughout the study, you might also have extra blood taken and possibly additional biopsies.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing new treatments before they are widely available, which might improve your outcomes. However, there are also risks, as these medicines can have side effects and may not work for everyone. The study team will closely monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Netherlands Cancer Institute
Verified postcode
Amsterdam, Netherlands
Royal Free London NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system find and fight cancer cells more effectively.

What does 'neoadjuvant' mean?

'Neoadjuvant' means the treatment is given before the main treatment, which in this case is surgery. It aims to shrink the tumour first.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctors will know which specific immunotherapy combination you are receiving.

How long will I be followed after the treatment?

You will be followed closely for up to two years after surgery, and then standard check-ups will continue for up to five years in total.

What if the treatment isn't shrinking my tumour?

The study has built-in checks. If a particular treatment group isn't showing enough tumour shrinkage, that group might be stopped early so you and your doctors can consider other options.