Efficacy and Safety of Pembrolizumab and Lenvatinib in Metastatic Uveal Melanoma: A Phase II Monocentric Single-Arm Study

The primary objective of this phase II, monocentric, single-arm trial is to evaluate the **efficacy** and **safety** of Pembrolizumab in combination with Lenvatinib in patients with **metastatic uveal melanoma**. This study aims to determine the therapeutic potential of this combination treatment in managing this aggressive form of melanoma, which is known for its poor prognosis and limited treatment options. The clinical relevance lies in potentially improving patient outcomes and expanding therapeutic strategies for metastatic uveal melanoma.

The clinical trial involves participants diagnosed with **metastatic uveal melanoma**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been disclosed. The trial aims to gather data from a diverse group of individuals without focusing on any particular lifestyle or demographic subgroup.

The clinical trial is designed to evaluate the efficacy and safety of **Pembrolizumab** in combination with **Lenvatinib** for patients with **metastatic uveal melanoma**. This is a phase II, monocentric, single-arm trial. The trial is expected to commence recruitment on July 7, 2022, and is estimated to conclude by January 7, 2027. Participants will be involved in a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Following the inclusion visit, participants will undergo regular follow-up visits to monitor treatment response and safety. The trial will culminate in an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the treatment regimen.

The expected duration of participant involvement will vary depending on individual response to treatment and the overall study timeline. Participants may be subject to early termination from the study if they experience adverse effects that compromise safety, fail to comply with study protocols, or withdraw consent. The trial's methodology ensures rigorous data collection and analysis to assess the primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial's design and procedures adhere to ethical standards and regulatory requirements to ensure the integrity and reliability of the findings.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific information, additional relevant details about drug administration, dosing schedules, and participant compliance monitoring are also not included. The absence of data on the experimental and non-experimental treatments limits the ability to provide a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy within the context of a Phase 4 study. The trial is scheduled to commence recruitment on July 7, 2022, with an estimated completion date of January 7, 2027. Efficacy assessments will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the standards expected in a Phase 4 clinical trial. The focus will be on evaluating the effectiveness of the intervention under real-world conditions, contributing to the understanding of its impact on the specified medical condition.