Study of INCB099280 for Patients with Advanced Solid Tumors Who Have Not Received Immunotherapy
This clinical trial examines the effects of an investigational medication called INCB099280 on advanced solid tumors that have either returned after treatment or spread to other parts of the body. The study is specifically for patients who have never received immunotherapy before.
Who can participate: Participants must be 18 years or older, have not received immunotherapy previously, and have measurable disease according to specific guidelines. They need a performance score of 0 or 1 on the ECOG scale, which measures the ability to perform daily activities. A life expectancy of more than 3 months is required, and participants must be willing to avoid pregnancy or fathering children during the study.
Who cannot participate: Patients who have already received immunotherapy are excluded, as the study is designed specifically for those who have not had this type of treatment. Patients with certain medical conditions not addressed by the study, those outside the specified age range, or those considered part of vulnerable populations not included in the study design cannot participate.
What the trial involves: Participants will take INCB099280 as a film-coated tablet orally, with doses of 400 mg, 600 mg, or 800 mg taken twice a day. The treatment can last up to 24 weeks. Some participants may receive a placebo for comparison purposes. Throughout the study, patients will be monitored for side effects and changes in their condition through physical examinations, vital signs checks, ECGs, and laboratory tests. The study aims to understand how safe and tolerable the treatment is and how well it works in managing tumors, including whether it can shrink them or stop them from growing.
Study on the Safety and Effects of XL092 with Nivolumab, Ipilimumab, and Relatlimab for Patients with Advanced Solid Tumors
This trial studies a combination of multiple medications for various types of advanced or metastatic solid tumors, including urothelial carcinoma. The treatment combines zanzalintinib with immunotherapy drugs including nivolumab, ipilimumab, and relatlimab. These medications are designed to work together to help the immune system fight cancer.
Who can participate: Patients must have a solid tumor that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. For most groups, the tumor must be measurable using a specific method called RECIST 1.1. Participants must provide a tumor tissue sample, either from a previous test or a new sample if safely obtainable. They must be 18 years or older and have a Karnofsky Performance Status of 70% or higher, which measures the ability to perform daily activities. Patients must have organs and bone marrow functioning well enough to handle the treatment and must have recovered from any side effects of previous treatments. Those who are sexually active and can have children must agree to use effective birth control during the study and for a certain time afterward.
Who cannot participate: Patients with different types of cancer than those specified, who have not received required previous treatments, have health conditions that might interfere with treatment, are pregnant or breastfeeding, or have participated in another recent clinical trial are excluded. Those with allergies to study medications, uncontrolled infections, or histories of certain heart, lung, liver, kidney, blood, immune system, neurological, or psychiatric conditions cannot participate. Patients unable to follow study procedures, attend required visits, or provide informed consent are also excluded.
What the trial involves: The study has two stages. During the dose-escalation stage, researchers determine the recommended dose of zanzalintinib when combined with other treatments, monitoring safety and tolerability closely. In the expansion stage, the effectiveness of zanzalintinib alone and in combination is assessed. Medications are administered in different ways: nivolumab, ipilimumab, and the relatlimab-nivolumab fixed-dose combination are given intravenously, while XL092 is taken orally as tablets. Throughout the trial, regular monitoring tracks any adverse events and measures tumor response through blood tests and imaging studies. The trial is expected to continue until December 31, 2030.
Summary
The three ongoing clinical trials for stage IV bladder transitional cell carcinoma offer patients access to cutting-edge immunotherapy-based treatments across multiple European countries. All three trials focus on combining immunotherapy drugs with other targeted agents to enhance the body's ability to fight cancer.
The geographic distribution shows that patients in Spain have access to two of the three trials, while Germany also hosts two trials. Other participating countries include Greece, Romania, Hungary, Austria, Poland, Italy, France, and Belgium, with most countries hosting one trial each. This wide distribution provides patients across Europe with opportunities to participate in research.
A notable pattern across all trials is the emphasis on immunotherapy combinations. Pembrolizumab appears in one trial, while nivolumab features in another, and INCB099280 represents a newer approach for patients who have never received immunotherapy. The trials are designed for different patient populations: some target first-line treatment settings where patients have not yet received therapy for their metastatic disease, while others focus specifically on immunotherapy-naive patients.
All trials require participants to have good overall health with adequate organ function and the ability to perform daily activities. The studies monitor both safety and effectiveness, tracking how well tumors respond to treatment and how long patients benefit from these therapies. These trials represent important steps in developing new treatment options for patients with advanced bladder cancer.
Austria
