Phase II Study of Durvalumab, Tremelimumab, and Olaparib in Solid Tumors with Homologous Recombination Repair Gene Mutations Post-Olaparib Response

The primary objective of this phase II study is to evaluate the **efficacy** of a double immunotherapy regimen consisting of **Durvalumab** and **Tremelimumab** in combination with **Olaparib** in patients with solid cancers who are carriers of homologous recombination repair genes mutation and have shown a response or stable disease following Olaparib treatment. This study is clinically relevant as it aims to determine the potential benefits of combining immunotherapy with a PARP inhibitor in a genetically defined patient population, which could lead to more personalized and effective treatment strategies for solid tumors.

The clinical trial involves **patients with solid cancers** and includes both male and female participants. The study population encompasses individuals within the age range of 18 to 64 years. Participants are not considered part of a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet or physical activity, have not been disclosed. The trial does not focus on a vulnerable population, and no additional key inclusion or exclusion criteria have been specified.

The clinical trial is a **phase II** study designed to evaluate the efficacy of a double immunotherapy regimen combining **Durvalumab** and **Tremelimumab** with **Olaparib** in patients with solid cancers who are carriers of homologous recombination repair genes mutation and have shown a response or stable disease after Olaparib treatment. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from February 10, 2020, to June 30, 2025, allowing for comprehensive data collection and analysis.

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 into treatment groups and will attend regular follow-up visits to monitor treatment response, safety, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will conclude the participant's involvement, 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 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 any protocol violations that compromise the integrity of the trial. The study is structured to ensure participant safety and the collection of high-quality data to inform future therapeutic strategies for patients with solid cancers.

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 within the context of a Phase 4 study. The trial is scheduled to conclude by June 30, 2025, with recruitment having commenced on February 10, 2020. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve standard methodologies appropriate for a Phase 4 study. These may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure efficacy. The analysis of efficacy data will be conducted in accordance with established clinical trial protocols, ensuring rigorous and objective evaluation of the treatment's impact. The trial's design and execution will adhere to the highest standards of clinical research to provide reliable and meaningful results.