The following is a summary of “Study Design and Rationale for Marble Study: A Phase II Trial of Atezolizumab (MPDL3280A) Plus Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Thymic Carcinoma (JTD2101),” published in the November 2023 issue of Pulmonology by Asao, et al.

Thymic carcinoma (TC) is an uncommon thymic epithelial growth, and the outlook is not good for people with advanced or recurring TC. When carboplatin and paclitaxel are used together, they don’t change how people with chemotherapy-naïve, advanced, or recurring TC are treated. This means that a new treatment plan is needed. Immune checkpoint blockades that stop the programmed cell death-1 (PD-1) pathway (PD-1 and its partner, PD-L1) have shown promise as a single treatment for TC, though they only worked moderately well for TC that had already been treated. 

For a study, researchers thought that using atezolizumab, an anti-PD-L1 antibody, carboplatin, and paclitaxel, would help kill immune cells in people with advanced or recurring TC. They started a phase II study at multiple centers using atezolizumab, carboplatin, and paclitaxel to treat TC that has spread or come back. The study was open-label and had one arm. Eligible patients will get atezolizumab, carboplatin, and paclitaxel every three weeks for up to six rounds. After that, they will get atezolizumab every three weeks for up to two years or until their cancer gets worse or the side effects become too much to handle. 

47 people were involved in the study, which will last for 24 months and then be followed up for 12 months. The objective response rate (ORR), which is based on a separate central review, is the main outcome. The additional outcomes are the ORR, disease control rate, progression-free survival, length of response, total survival, and safety as judged by the investigators. The goal of the study is to find out if atezolizumab mixed with carboplatin and paclitaxel is safe and effective for people with advanced or recurrent TC.

Source: sciencedirect.com/science/article/abs/pii/S1525730423000992