Assessment of Cardiac Function Evolution in Cancer Patients Undergoing PD-1 Inhibition with Nivolumab and Pembrolizumab

The primary objective of this study is to describe the evolution of **left ventricular function** in patients treated with nivolumab or pembrolizumab, based on recommended monitoring data in a Cardio-Oncology unit. This is clinically relevant as it aims to assess potential cardiac effects of these anticancer immunotherapies, which are crucial for patient safety and treatment efficacy in cancer management.

Secondary objectives include:

• Describing the evolution of **right ventricular function** in patients treated with nivolumab, utilizing recommended monitoring data.
• Describing the evolution of **cardiac rhythm** in patients treated with nivolumab or pembrolizumab, based on recommended monitoring data.

The clinical trial involves participants diagnosed with **cancer**, focusing on the evolution of left ventricular function in patients treated with nivolumab or pembrolizumab. 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. Participants are not part of a vulnerable population. The trial population was selected from patients who are receiving treatment with nivolumab or pembrolizumab in participating departments and are affiliated with a national insurance scheme. The sponsor has not provided the total number of participants involved in the study. No specific lifestyle considerations such as diet or physical activity are mentioned in the available data.

The clinical trial is designed to evaluate the **evolution of left ventricular function** in patients undergoing treatment with **nivolumab** or **pembrolizumab**. This is a Phase IV, randomized, double-blind, controlled study focusing on patients with **cancer**. The trial will span approximately eight years, with an estimated recruitment start date of April 9, 2018, and an anticipated end date of October 8, 2026. Participants will be randomly assigned to receive either nivolumab or pembrolizumab via intravenous infusion, with a maximum daily dose of 480 mg for nivolumab and 400 mg for pembrolizumab, over a treatment period of up to six months.

The study will include several key visits: an initial screening visit to confirm eligibility based on inclusion criteria, which require patients to be selected for treatment with either drug and affiliated with a national insurance scheme. Following the screening, participants will undergo regular follow-up visits to monitor cardiac function, specifically measuring the global longitudinal strain value as the primary endpoint. These follow-up visits are crucial for assessing the primary objective of the trial, which is to describe the evolution of left ventricular function in the context of recommended monitoring data in a Cardio-Oncology unit. The trial will conclude with an end-of-study visit to evaluate the overall outcomes and gather final data.

Participant involvement is expected to last for the duration of the treatment period, with additional time allocated for follow-up assessments. Conditions that may lead to early termination from the study include adverse reactions to the treatment, withdrawal of consent, or any significant protocol deviations. The trial is not categorized as low intervention, and it is conducted under rigorous scientific and ethical standards to ensure the safety and well-being of all participants.

The clinical trial involves the administration of **Nivolumab**, an experimental medication used to evaluate cardiac function during anticancer immunotherapy. Nivolumab is a monoclonal antibody classified under the ATC code L01FF01. It is administered in the form of an intravenous infusion, with a maximum daily dose of 480 mg. The treatment period for Nivolumab is set at a maximum of six months. The pharmaceutical form is identified as PHF00230MIG, and the active substance is derived from a protein of other origin. The administration schedule and participant compliance are monitored to ensure adherence to the dosing regimen.

Another experimental medication used in the trial is **Pembrolizumab**, also a monoclonal antibody, classified under the ATC code L01FF02. Pembrolizumab is administered via intravenous infusion, with a maximum daily dose of 400 mg. Similar to Nivolumab, the treatment period for Pembrolizumab is also set at a maximum of six months. The pharmaceutical form is PHF00230MIG, and the active substance is derived from a protein of other origin. The administration schedule and participant compliance are closely monitored to ensure proper adherence to the dosing regimen.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in the study. The trial focuses on the evolution of left ventricular function in patients treated with either Nivolumab or Pembrolizumab, based on recommended monitoring data in a Cardio-Oncology unit. The study does not involve pediatric formulations, and neither of the drugs is classified as an orphan drug. The trial is designed to provide insights into the cardiac effects of PD-1 inhibiting immunotherapy.

Efficacy in this clinical trial will be assessed by evaluating the evolution of left ventricular function in patients treated with **nivolumab** or **pembrolizumab**. The primary endpoint for efficacy assessment is the change in left ventricular function, which will be measured using the global longitudinal strain value. This parameter will provide insights into the cardiac function of patients undergoing treatment with these immunotherapy agents. The trial aims to monitor these changes based on recommended data collection practices within a Cardio-Oncology unit. The assessment will be conducted throughout the treatment period, which is set to a maximum of six months for each patient. The trial is designed as a Phase IV clinical trial, focusing on the real-world application and monitoring of these treatments in a clinical setting.