Wednesday, June 15, 2022 Trial closure notification for IND235, CO26 and MAC13. IND235: A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination with Ipilimumab for the Treatment of Patients with Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay The purpose of this study - to determine the safety and effectiveness of nivolumab alone or in combination with ipilimumab in patients with metastatic or unresectable tumors harbouring mutations in genes, POLE and POLD1. These mutations will be determined by plasma cfDNA. Nivolumab and ipilimumab have been given to patients across multiple types of cancer, and safe doses and schedules have been determined. For more information please visit the IND235 trial page CO26: A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients with Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies This is a multi-centre, phase II study of doublet immunotherapy (durvalumab + tremelimumab) and best supportive care versus best supportive care only in patients with advanced colorectal cancer who are refractory to all available therapy. The purpose of this study is to determine the effect on overall survival (OS) of the combination of durvalumab and tremelimumab and best supportive care versus best supportive care only in patients with refractory, advanced colorectal cancer. For more information please visit the CO26 trial page. MAC13: Adjuvant, Lapatinib and/or Trastuzumab Treatment Optimisation StudyA Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). For more information please visit the MAC13 trial page. The memos are posted to each of the trial pages as well as the permanent trial closure page.
