Phase I/II Study of Avelumab and Methotrexate in First-Line Treatment of Low-Risk Gestational Trophoblastic Neoplasia

The primary objective of the study is to evaluate the efficacy and safety of **Avelumab** in combination with **Methotrexate** as a first-line treatment for patients with low-risk gestational trophoblastic neoplasia. This is clinically relevant as it aims to establish a potentially effective treatment regimen for this condition, which could improve patient outcomes and provide an alternative to existing therapies.

The clinical trial focuses on participants diagnosed with **low-risk gestational trophoblastic neoplasia**. The study population comprises exclusively female subjects, as indicated by the trial's design, with an age range categorized under code "3," which typically corresponds to adults. The trial does not include male participants, and it does not target a vulnerable population. The sponsor has not provided information regarding the total number of participants involved in the study. Selection criteria, including any lifestyle considerations such as diet or physical activity, have not been disclosed. The absence of specific inclusion or exclusion criteria in the available data suggests that such details are either not defined or not shared by the sponsor.

The clinical trial is designed to evaluate the efficacy and safety of **Avelumab** and **Methotrexate** in patients with low-risk gestational trophoblastic neoplasia. This study is structured as a phase I/II trial, employing a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The trial is expected to commence recruitment on June 24, 2024, and is projected to conclude by July 16, 2027, encompassing a total duration of approximately three years.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to confirm eligibility based on predefined criteria. Following successful inclusion, participants will be randomized into treatment groups. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' response to the treatment and to assess any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to evaluate the overall outcomes of the treatment regimen.

The expected length of participant involvement in the trial is contingent upon the individual treatment response and the study's predefined schedule. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial's design and procedures are meticulously crafted to ensure the ethical and scientific integrity of the research, with the ultimate goal of advancing treatment options for low-risk gestational trophoblastic neoplasia.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Therefore, a description of these elements is not possible based on the current data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is set to commence recruitment on June 24, 2024, with an estimated completion date of July 16, 2027. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the study duration. The trial's design will ensure that efficacy assessments are conducted systematically to provide reliable and scientifically valid results.