Phase II Multicenter Randomized Open-Label Study of Relatlimab and Nivolumab Versus Nivolumab in Locally Advanced Cervical Cancer

The primary objective of this study is to evaluate the efficacy of **relatlimab** in combination with **nivolumab** compared to nivolumab alone in patients with locally advanced cervical cancer. This is clinically relevant as it aims to determine whether the addition of relatlimab can enhance the therapeutic outcomes in this patient population, potentially offering a more effective treatment option for those with cervical squamous or adenosquamous carcinoma at specific stages according to FIGO 2018, without evidence of metastatic disease and no prior anti-cancer treatment.

The clinical trial involves **female** participants diagnosed with cervical squamous or adenosquamous carcinoma, specifically at stage IB3 if N>=1 or stages II to IVA, according to FIGO 2018, with no evidence of metastatic disease (M0) and without any prior anti-cancer treatment. The study population is comprised of adults, with an **age range** corresponding to categories 3 and 4, which typically includes individuals from young adulthood to middle age. The trial does not include male participants or vulnerable populations. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity. The selection of the trial population is based on the presence of the specified medical condition and the absence of previous cancer treatments.

The clinical trial is designed as a **randomized**, open-label, Phase II study comparing the efficacy of relatlimab and nivolumab versus nivolumab alone in patients with locally advanced cervical cancer. The trial will commence recruitment on September 30, 2024, and is expected to conclude by March 31, 2030. Participants will be individuals with a histologically confirmed diagnosis of cervical squamous or adenosquamous carcinoma, specifically stages IB3 (if N≥1) to IVA, according to FIGO 2018, with no evidence of metastatic disease (M0) and no prior anti-cancer treatment.

The trial will involve a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on the specified criteria. Following successful screening, participants will be randomized into one of the two treatment arms. The study will include regular follow-up visits to monitor the participants' response to treatment and any adverse events. These visits will be scheduled at predetermined intervals throughout the trial duration. The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to evaluate the primary and secondary endpoints of the study.

Participant involvement is expected to last until the end of the study, unless early termination is warranted. Conditions that may lead to early withdrawal include significant adverse events, disease progression, or withdrawal of consent by the participant. The trial's methodology ensures rigorous monitoring and data collection to maintain the integrity and reliability of the study outcomes.

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 has orphan drug status. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized under Phase 4, indicating it is conducted after the approval of the treatment to gather additional information on the drug's effect in various populations and any side effects associated with long-term use. The trial is scheduled to commence recruitment on September 30, 2024, with an estimated completion date of March 31, 2030. The efficacy assessment will be conducted at predetermined intervals throughout the trial duration, although specific timepoints and methods for measuring efficacy parameters are not detailed in the provided data. The trial will adhere to rigorous standards to ensure the collection and analysis of efficacy data are conducted systematically and objectively.