Evaluation of CC-90010 in Combination with Standard Therapy in Patients with Newly Diagnosed WHO Grade IV Glioblastoma Post-Tumor Resection

The primary objective of this study is to evaluate the efficacy of adding the experimental drug **CC-90010** to the standard treatment regimen for patients with newly diagnosed WHO Grade IV **glioblastoma** (ndGBM) who have undergone complete or partial tumor resection. This investigation is clinically relevant as it aims to determine whether the inclusion of CC-90010 can improve treatment outcomes in this aggressive form of brain cancer, potentially offering a new therapeutic option for affected patients.

The clinical trial involves **subjects** with newly diagnosed WHO Grade IV **glioblastoma** who have undergone complete or partial tumor resection. The study population includes both male and female participants, with an age range that encompasses adults and older adults. The trial population was selected to include individuals who are considered part of a vulnerable population. However, the sponsor has not provided information regarding the total number of participants. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. Key inclusion or exclusion criteria have not been detailed by the sponsor.

The clinical trial is designed to evaluate the addition of an experimental drug, CC-90010, to the standard treatment regimen for patients with newly diagnosed **glioblastoma** (WHO Grade IV) who have undergone complete or partial tumor resection. This study is a Phase 3, randomized, double-blind, controlled trial, which aims to assess the efficacy and safety of the investigational drug in combination with the usual care. The trial is expected to span from July 10, 2020, to August 12, 2026, encompassing both the recruitment and follow-up periods.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomly assigned to either the experimental group receiving CC-90010 or the control group receiving standard treatment. The trial will include multiple follow-up visits to monitor the participants' health status, treatment response, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected duration of participant involvement in the trial will vary depending on individual response to treatment and the occurrence of any adverse events. Participants may be withdrawn from the study early if they experience significant adverse effects, if the disease progresses despite treatment, or if they choose to withdraw consent. The trial is conducted under strict ethical guidelines to ensure the safety and well-being of all participants throughout the study duration.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

The clinical trial is in Phase 3 and is scheduled to conclude on August 12, 2026. The recruitment for the trial began on July 10, 2020. The efficacy of the intervention will be assessed through predefined primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured methodology to ensure the accurate measurement and analysis of efficacy parameters. The trial's design and execution will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments.