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

3 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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.
  • 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 Study?

  • 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.

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
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Hôpital Européen Georges-Pompidou Paris France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nimes Nimes France
Hospital San Pedro De Alcantara Caceres Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hopital Prive Toulon Hyeres Sainte Marguerite Hyeres France
Hospital General Universitario De Valencia Valencia Spain
Unite De Recherche Clinique HIA Begin Saint-Mande France
Hospital Alvaro Cunqueiro Vigo Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Clinique Victor Hugo Le Mans France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Isopkgvi Rucvpqfz Dq Ctbkxe Dy Mfrsznshkdz Montpellier France
Cgqlvk Lkcc Bslbde Lyon France
Ignztztf Cvjluq Dtbovpskjtycbzjtv L'hospitalet De Llobregat Spain
Iwvaxhdr Muljsmbfnf Mgsllulmev Paris France
Cey dnhfgqzgkpiskq Epagny Metz Tessy France
Htmvurzt clxnrf Hxuur Msklde is Awovcpbw Aurillac France
Ikizgqfd du Chifhpjkhwqt Hyflocmkrhe Uwqxzmfwgqrtn dq Sveox Eqnjvbj (jldvmup Saint Priest En Jarez France
Hsgjycjz Vpgk dbbxlxiu Barcelona Spain
Idffdriu Pyeqmjczbvltmvt Cpsetv Cugifk Marseille France
Hmmlksra Uqzzrrdaklfbpb Ssdfqtrkgs &tkumtj Hkxxquy dh Hkspsreaeiw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
22.07.2021
Spain Spain
Not yet recruiting
22.07.2021

Trial locations

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.

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.

Trial ID:
2024-513219-29-00
NCT ID:
NCT03288532
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Belzutifan and Zanzalintinib in Adults with Advanced Renal Cell Carcinoma After PD-1/L1 and VEGF-TKI Therapy

    Recruiting

    3 1 1
    Czechia Denmark France Germany Greece Italy +3
  • A study of belzutifan and lenvatinib for patients with von Hippel-Lindau disease-associated tumors or other specific solid tumors.

    Recruiting

    3 1 1
    Investigated drugs:
    Belgium Czechia Denmark Finland France Germany +4