Phase 1b/II Multicenter Trial of Neoadjuvant Intradermal Ipilimumab and Nivolumab in High-Risk Stage II Melanoma Patients

The primary objective of this multicenter phase 1b/II trial is to evaluate the efficacy and safety of **neoadjuvant intradermal Ipilimumab and Nivolumab** in patients with high-risk **stage II melanoma**. This study aims to determine the potential benefits of this treatment approach in reducing tumor burden and improving patient outcomes in this specific melanoma stage, which is crucial for optimizing therapeutic strategies and enhancing survival rates.

The clinical trial involves participants diagnosed with **stage II 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 focus on 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 specified. The trial aims to gather data from a diverse group of individuals without targeting any specific vulnerable groups.

The clinical trial is a **multicenter phase 1b/II** study designed to evaluate the efficacy and safety of neoadjuvant intradermal administration of Ipilimumab and Nivolumab in patients with high-risk **stage II melanoma**. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial is approximately one year, with recruitment starting on October 1, 2023, and the trial expected to conclude by October 1, 2024.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational treatment or a control. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' response to treatment and to collect data on safety and efficacy endpoints. The end-of-study visit will occur at the conclusion of the treatment period, where final assessments will be conducted to evaluate the overall outcomes of the trial.

The expected length of participant involvement in the study is approximately 12 months, contingent upon individual response to treatment and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or non-compliance with study procedures. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

The clinical trial is designed to assess efficacy within the context of a Phase 4 study. The trial is scheduled to commence recruitment on October 1, 2023, with an estimated completion date of October 1, 2024. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will adhere to standard protocols for data collection and analysis, ensuring that all efficacy-related data is systematically gathered and evaluated. The study will follow a structured timeline, with assessments likely occurring at regular intervals throughout the trial period, although specific timepoints are not provided. The trial's design and execution will be in accordance with regulatory standards for Phase 4 studies, focusing on the post-marketing evaluation of the intervention's effectiveness.