Study of Subcutaneous Nivolumab for Patients with Previously Treated Advanced or Metastatic Clear Cell Kidney Cancer

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as advanced or metastatic clear cell renal cell carcinoma. This is a condition where cancer cells form in the lining of the tubules in the kidney and have spread to other parts of the body. The study is investigating a treatment called nivolumab, which is a medication that helps the immune system fight cancer. Nivolumab is being tested in two forms: one that is given through a vein, known as intravenous nivolumab, and another that is injected under the skin, called subcutaneous nivolumab. The subcutaneous form is also referred to by its code name, BMS-986298.

The purpose of this study is to compare the effectiveness of the subcutaneous form of nivolumab to the intravenous form in patients who have already received other treatments for their cancer. Participants in the study will be randomly assigned to receive either the subcutaneous or intravenous form of nivolumab. The study will monitor how the medication is processed in the body and its effects on the cancer over time. Some participants may receive a placebo, which is a substance with no active medication, to help compare the results.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of their cancer. The study aims to provide valuable information on whether the subcutaneous form of nivolumab is as effective as the intravenous form, potentially offering a more convenient treatment option for patients with advanced kidney cancer. The study is expected to continue for several years to gather comprehensive data on the treatment’s long-term effects and safety.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of advanced or metastatic clear cell renal cell carcinoma.

Eligibility criteria include having received no more than two prior systemic treatments and showing intolerance or progression after the last treatment.

2 randomization

Participants are randomly assigned to receive either subcutaneous nivolumab or intravenous nivolumab. This process ensures that each participant has an equal chance of receiving either form of the medication.

3 treatment administration

The treatment involves the administration of nivolumab, which is a medication used to treat certain types of cancer.

For those receiving the intravenous form, the medication is given as a solution for infusion. For those receiving the subcutaneous form, it is given as a solution for injection.

4 monitoring and follow-up

Participants are monitored for their response to the treatment and any side effects. This includes regular blood tests and imaging studies to assess the cancer’s response.

The study measures various outcomes, such as the time-averaged serum concentration of the medication and the objective response rate, over a period of up to five years.

5 completion of study

The study is expected to conclude by February 2025. Participants will continue to be monitored for long-term outcomes, including overall survival and progression-free survival.

Who Can Join the Study?

  • You must have a confirmed diagnosis of renal cell carcinoma (RCC), which is a type of kidney cancer, with a clear cell component. This includes cases that may have sarcomatoid features, which are specific characteristics of the cancer cells.
  • Your RCC must be advanced, meaning it cannot be cured with surgery or radiation, or it must be metastatic, which means the cancer has spread to other parts of the body (Stage IV).
  • You must have a measurable disease as defined by specific criteria used to assess tumors, known as RECIST v1.1, within 28 days before being randomly assigned to a treatment group.
  • You should have received no more than 2 previous systemic treatment regimens, which are treatments that affect the entire body, such as chemotherapy.
  • You must have experienced intolerance (unable to tolerate) or progression (worsening) of the disease on or after the last treatment regimen you received, and this must have occurred within 6 months before being randomly assigned to a treatment group.
  • Your Karnofsky Performance Status (PS) must be 70 or higher at the time of screening. This is a scale that measures your ability to perform everyday activities, with 100 being fully active and 0 being deceased.
  • If applicable, you must agree to follow specific methods of contraception to prevent pregnancy during the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have an infection that requires treatment with antibiotics.

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
Azienda Ospedaliero Universitaria Careggi Florence Italy
Medisprof S.R.L. Cluj Napoca Romania

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Hospital Foch Suresnes France
Azienda Ospedaliera S Maria Di Terni Terni Italy
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
San Camillo Forlanini Hospital Rome Italy
Spital Clinic Militar De Urgenta Dr. Constantin Papilian Cluj Napoca Cluj Napoca Romania
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Virgen del Rocío University Hospital Sevilla Spain
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Pirkanmaan hyvinvointialue Tampere Finland
Acdspnu Oyldieinbed Uodavqztliqfu Pcgnt Parma Italy
Iwycbzgl Rsbrtghcx Prk Lo Swcyqh Djb Tobleu Drjh Aojhzfb Iibd Szmjyb Meldola Italy
Nddiyont Iweqwfsk Owxwyrpbe Irl Mvvzm Sovflfyyoncsflglnirdaaxlztye Ijkefvdt Bznmwcps Cracow Poland
Ulopujtcxlusco Cccrskz Krxssdwms Gdansk Poland
Fpgqtjvou Plqk Lq Ipylmoaxpftms Boezyijxf Dqy Hxrmqnfn Usibiyjjostlk Ls Pne Madrid Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
13.07.2021
Finland Finland
Not recruiting
13.07.2021
France France
Not recruiting
13.07.2021
Ireland Ireland
Not recruiting
13.07.2021
Italy Italy
Not recruiting
13.07.2021
Poland Poland
Not recruiting
13.07.2021
Portugal Portugal
Not recruiting
13.07.2021
Romania Romania
Not recruiting
13.07.2021
Spain Spain
Not recruiting
13.07.2021

Trial locations

Investigated drugs:

Nivolumab: This medication is used in the trial to treat participants with advanced or metastatic clear cell renal cell carcinoma. It is an immunotherapy drug that helps the body’s immune system to fight cancer cells. In this study, Nivolumab is being tested in two different forms of administration: subcutaneous (under the skin) and intravenous (into a vein). The trial aims to compare these two methods to see if the subcutaneous form is as effective as the intravenous form.

Metastatic Clear Cell Renal Cell Carcinoma – This is a type of kidney cancer that originates in the cells lining the small tubes within the kidney. It is characterized by the spread of cancer cells beyond the kidney to other parts of the body, such as the lungs, bones, or liver. The disease often progresses silently in its early stages, making it difficult to detect until it has metastasized. As it advances, symptoms may include blood in the urine, persistent pain in the side or back, and unexplained weight loss. The progression of the disease can vary, with some individuals experiencing rapid spread while others may have a slower course. The clear cell subtype is the most common form of renal cell carcinoma, known for its distinct appearance under a microscope.

Trial ID:
2023-503280-42-00
Protocol code:
CA209-67T
NCT ID:
NCT04810078
Trial Phase:
Therapeutic confirmatory (Phase III)

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