Ongoing Clinical Trials for Stage IV Renal Cancer
Currently, there is 1 ongoing clinical trial for patients with stage IV renal cancer (also known as advanced kidney cancer, metastatic kidney cancer). This trial is investigating a new medication for patients who have not previously received immunotherapy and is being conducted across multiple European countries.
Clinical trial locations
- Greece
- Hungary
- Romania
Study of INCB099280 for Patients with Advanced Solid Tumors Who Have Not Received Immunotherapy
This clinical trial is studying a new treatment called INCB099280 for patients with advanced solid tumors, including stage IV renal cancer. The study is specifically designed for patients who have not previously received immunotherapy, a type of treatment that helps the body’s immune system fight cancer.
Main inclusion criteria:
- Must be 18 years or older
- Must not have received immunotherapy before
- Must have measurable disease according to specific guidelines (RECIST v1.1)
- Must have a life expectancy of more than 3 months
- Must have a performance score of 0 or 1 on the ECOG scale, which measures daily living abilities
- Must be willing to understand and sign a written consent form
- Must be willing to avoid becoming pregnant or fathering children during the study
Main exclusion criteria:
- Patients who have already received immunotherapy for their cancer
- Patients who have certain medical conditions that the study is not designed to treat
- Patients who are not within the specified age range for the study
- Patients who are part of a vulnerable population that the study is not designed to include
Focus and goals of the trial:
The main purpose of this study is to understand how safe and tolerable INCB099280 is, and to see how well it works in managing advanced solid tumors. Researchers are looking to evaluate whether the treatment can shrink tumors or stop them from growing. They will also assess how long any positive effects last and how the treatment impacts the overall health and survival of participants.
The study will monitor participants regularly through physical examinations, vital signs checks, and ECGs. Clinical laboratory samples will be analyzed to watch for any treatment-related side effects. Researchers will evaluate the objective response, disease control, duration of response, time to response, progression-free survival, and overall survival.
Investigational drug:
The medication being tested is INCB099280, which is taken orally as a film-coated tablet. The study is testing different doses: 400 mg, 600 mg, and 800 mg, taken twice a day. The treatment period can last up to 24 weeks. Some participants may receive a placebo, which is a tablet that looks like the treatment but does not contain the active medication.
INCB099280 works by modulating the immune system to enhance the body’s ability to fight cancer cells. It is classified as an immune checkpoint inhibitor and is currently being studied for its safety, tolerability, and preliminary effectiveness in treating advanced solid tumors.
Summary
There is currently one clinical trial available for patients with stage IV renal cancer who have not previously received immunotherapy. This trial is being conducted across three European countries: Greece, Hungary, and Romania. The study focuses on investigating INCB099280, an immune checkpoint inhibitor administered in oral tablet form at various dosages. The trial represents an opportunity for patients with advanced disease who meet the specific eligibility criteria and are seeking new treatment options through clinical research.
