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Study on Durvalumab and Tremelimumab for Patients with Kidney Cancer at Risk of Recurrence After Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The clinical trial is focused on studying a type of kidney cancer known as Renal Cell Carcinoma (RCC). This trial is investigating whether treatment with a medication called Durvalumab, either alone or in combination with another medication called Tremelimumab, can help delay the return of cancer or increase life expectancy in patients who have had surgery to remove their kidney cancer and are at a higher risk of the cancer coming back. Durvalumab is also known by its code name, MEDI4736.

The purpose of the study is to compare these treatments with the current standard approach, which involves active monitoring after surgery. Patients participating in the trial will receive the medications through an infusion, which is a way of delivering the treatment directly into the bloodstream. The study will follow patients over a period to observe the effects of the treatments on the return of cancer and overall survival.

Throughout the study, some patients will receive the medications, while others may receive a placebo. The trial aims to provide valuable information on whether these treatments can offer better outcomes for patients with Renal Cell Carcinoma after surgery. Participants will be monitored regularly to assess their health and any changes in their condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be randomly assigned to one of the treatment groups. This means you will either receive the medication or be part of the active monitoring group. The assignment is random to ensure fairness and accuracy in the trial results.
Step 2
Treatment with durvalumab
If assigned to the durvalumab group, you will receive a medication called durvalumab. This is given as an infusion, which means it is administered directly into your bloodstream through a vein. The dosage is 50 mg/mL and the frequency and duration will be explained by the medical team.
Step 3
Treatment with durvalumab and tremelimumab
If assigned to the combination treatment group, you will receive both durvalumab and tremelimumab. These are also given as infusions. Durvalumab is administered at a dosage of 50 mg/mL and tremelimumab at 20 mg/mL. The medical team will provide details on the frequency and duration of these infusions.
Step 4
Active monitoring
If assigned to the active monitoring group, you will not receive the trial medications. Instead, your health will be closely monitored through regular check-ups and tests to observe any changes in your condition.
Step 5
Regular follow-ups
Throughout the trial, you will have regular follow-up appointments. These appointments are important to monitor your health, manage any side effects, and assess the effectiveness of the treatment. The schedule for these follow-ups will be provided by the medical team.
Step 6
End of trial participation
At the end of your participation in the trial, you will have a final assessment. This will include a review of your health status and any changes observed during the trial. The medical team will discuss the next steps and any further treatment options if necessary.

Who can join the trial?

18 criteria

The patient must have a confirmed diagnosis of Renal Cell Carcinoma (RCC), a type of kidney cancer. All types of RCC are allowed, except for certain rare types. There should be no visible cancer left after surgery, as shown by a CT scan.
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The patient must have normal functioning of organs and bone marrow, which includes:
- Hemoglobin level of at least 9.0 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
- Absolute Neutrophil Count (ANC) of at least 1.5 x 10⁹/L. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count of at least 100 x 10⁹/L. Platelets help with blood clotting.
- Bilirubin level of no more than 1.5 times the upper limit of normal (ULN). Bilirubin is a substance made during the breakdown of red blood cells.
- AST/ALT levels of no more than 2.5 times the ULN. These are enzymes that help assess liver function.
- Creatinine Clearance level greater than 40 mL/min, which measures kidney function.
- The patient must be at least 18 years old.
- The patient must provide written informed consent to participate in the study.
- Both men and women must agree to use contraception during the study and for 6 months after. They must avoid donating eggs or sperm and breastfeeding during this time.
- Female patients who are not post-menopausal must have a negative pregnancy test. Post-menopausal means having no menstrual periods for 12 months without another medical reason.
- The patient must have a Leibovich score between 3 and 11, which helps assess the risk of cancer returning.
- Patients with certain types of metastases (cancer spread) that have been completely removed by surgery are eligible.
- The patient must have had surgery to remove the kidney cancer at least 28 days but no more than 91 days before joining the study.
- A CT scan must be done within 28 days before joining the study to ensure no visible cancer is left.
- Patients with microscopic cancer cells left after surgery are eligible if the CT scan shows no visible cancer.
- The patient must have a WHO Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
- The patient must agree to provide tissue samples from their surgery and blood samples for future research.

Who cannot join the trial?

4 criteria

Patients who have not had surgery for their kidney cancer.
Patients who are not at intermediate or high risk of their cancer coming back.
Patients who are not able to receive the study medications, **durvalumab** or **tremelimumab**.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Durvalumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, durvalumab is being tested to see if it can help prevent kidney cancer from coming back after surgery and if it can help patients live longer.
Tremelimumab
is another immunotherapy medication. It is used in combination with durvalumab in this trial. Tremelimumab also helps the immune system fight cancer by targeting specific proteins that can stop the immune system from working properly. The combination of tremelimumab and durvalumab is being studied to see if it is more effective than monitoring alone in preventing the return of kidney cancer and increasing life expectancy after surgery.

What is already known about the treatment

Durvalumab
Durvalumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating renal cell carcinoma, a type of kidney cancer, particularly after surgery in patients at high or intermediate risk of the cancer returning. The medication works by blocking a specific protein on cancer cells, which helps the immune system recognize and attack these cells more effectively. Durvalumab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.
Tremelimumab
Tremelimumab is also given as an intravenous infusion, allowing it to enter the bloodstream directly. It is being tested in combination with durvalumab in clinical trials for renal cell carcinoma, aiming to prevent the cancer from returning after surgery in patients at risk. Tremelimumab works by targeting a different protein on immune cells, enhancing the immune response against cancer cells. Like durvalumab, it is classified as an immune checkpoint inhibitor, which helps the immune system better identify and destroy cancer cells.

Investigated diseases

Renal Cell Carcinoma – Renal Cell Carcinoma is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It typically begins as a single mass or tumor in one kidney, but it can also occur in both kidneys simultaneously. As the disease progresses, the tumor may grow larger and invade nearby tissues or spread to other parts of the body, such as the lungs, bones, or liver. The cancer cells can also enter the bloodstream or lymphatic system, leading to metastasis. Symptoms may include blood in the urine, a lump in the abdomen, or persistent pain in the side. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly.