Durvalumab and tremelimumab in combination with metronomic oral vinorelbine for recurrent advanced cervical cancer: an open-label phase I/II study

• DOI: 10.1136/jitc-2024-010708
• Publication Date: 2025-01-07T19:20:23Z
• Authors: Jean-Sébastien Fr...; Laurent Mathiot; Claire Cropet; Edith Borcoman; Alice Hervieu; Elodie Coquan; Thibault De La Mo...; Esma Saada-Bouzid; Renaud Sabatier; Pernelle Lavaud; Marta Jimenez; François Legrand; Olivia Le Saux; Emmanuelle Charafe; Anthony Gonçalves
• Keywords: Tremelimumab; Durvalumab; Vinorelbine; Clinical endpoint

Background The MOVIE phase I/II trial ( NCT03518606 ) evaluated the safety and antitumor activity of durvalumab tremelimumab combined with metronomic oral vinorelbine in patients advanced tumors. We present results recurrent cervical cancer cohort. Methods Patients received (intravenously, 75 mg, every four weeks (Q4W); cycles max) plus 1,500 Q4W; 26 (40 three (3QW)) until disease progression. primary efficacy endpoint was clinical benefit rate (CBR) based on Response Evaluation Criteria Solid Tumors V.1.1, which analyzed using a Bayesian approach Results A total 31 were enrolled treated median number previous lines chemotherapy for 2 (0–6), all (100%) 12 (38.7%) pretreated cisplatin bevacizumab, respectively. At data cut-off, follow-up duration 12.8 (Q1–Q3, 6.1–34.6) months. CBR 53.1% (95% CI, 36.0% to 69.8%), non-informative prior distribution (beta(1, 1)). overall response 41.9%, five achieved complete (16.1%), eight (25.8%) had partial irrespective histological subtype or programmed death-ligand 1 (PD-L1) expression. Of patients, 28 (90.3%) experienced treatment-related adverse events (TRAEs), 13 (41.9%) reported grade ≥3 immune-related (AEs), chemotherapy-related AEs. definitive discontinuation due TRAEs 16.1%. Conclusions Dual checkpoint blockade PD-L1 cytotoxic T-lymphocyte-associated antigen-4 demonstrated meaningful durable previously cancer. Toxicity significant but manageable.