Phase 1 Evaluation of BMS-986416 with and without Nivolumab in Patients with Solid Tumors

The primary objective of this study is to evaluate the safety and tolerability of **BMS-986416** with and without **Nivolumab** in patients with **solid tumors**. This is clinically relevant as it aims to determine the potential therapeutic benefits and adverse effects of the investigational drug combination, which could inform future treatment strategies for solid tumors. No secondary objectives are provided in the available data.

The clinical trial involves a total of **134 participants** diagnosed with **solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The general health status of the participants is not specified, nor are any lifestyle considerations such as diet, physical activity, or habits. The trial aims to gather data from a diverse group, ensuring representation across different age groups and genders.

The clinical trial is designed to evaluate the safety and efficacy of BMS-986416 with and without **Nivolumab** in patients with **solid tumors**. This is a Phase 2, randomized, double-blind, controlled study. The trial is expected to commence recruitment on June 5, 2023, and is estimated to conclude by July 15, 2028. Participants will be randomly assigned to receive either the investigational drug alone or in combination with Nivolumab, with neither the participants nor the investigators aware of the group assignments, ensuring the double-blind nature of the study.

The trial will include several key study visits. Initially, a screening visit will be conducted to assess eligibility based on predefined inclusion and exclusion criteria. Following successful screening, participants will be enrolled and randomized into the study. Throughout the trial, participants will attend regular follow-up visits to monitor safety, drug tolerability, and any adverse events. These visits will also involve assessments of tumor response and overall health status. The end-of-study visit will occur after the final treatment cycle, where comprehensive evaluations will be conducted to gather data on the primary and secondary endpoints.

Participant involvement is expected to last for the duration of the treatment cycles, with additional time allocated for follow-up assessments. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The study is structured to ensure rigorous monitoring and data collection, contributing to the understanding of the investigational drug's potential benefits and risks in treating solid tumors.

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. Additionally, details about drug administration, dosing schedules, and participant compliance monitoring are not included in the source data. Consequently, no further information can be offered regarding the substances or treatments involved in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on June 5, 2023, with an estimated completion date of July 15, 2028. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the available data. The trial will follow a structured methodology to ensure the collection and analysis of efficacy data, adhering to the standards expected in clinical research. The trial phase indicates a focus on evaluating the effectiveness and further safety of the intervention, typically involving a larger group of participants than Phase 1. The absence of detailed endpoints or measurement tools in the provided data suggests that these elements will be defined in the full trial protocol, ensuring a comprehensive approach to efficacy assessment.