A randomized phase II trial evaluating the efficacy of a nivolumab monotherapy lead in "window" or commencement of nivolumab concurrently with paclitaxel and carboplatin as neoadjuvant therapy in early stage triple negative breast cancers (BCT 1902 Neo-N Cohorts A & B)

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COHORTS A & B. Dataset of 110 triple negative breast cancer patients in a randomised, non-comparative "pick-the-winner"study. ARM A - Nivolumab window: Nivolumab monotherapy 240 mg IV, 2 weeks later followed by Nivolumab 360 mg IV with Carboplatin AUC5 once every 3 weeks for 4 cycles and Paclitaxel 80 mg/m^2 every week for 12 weeks as an IV infusion administered per institutional guidelines. This will be followed by surgery a minimum of 2 weeks and a maximum of 4 weeks after the last dose of paclitaxel. ARM B - Concurrent Nivolumab: Nivolumab 360 mg IV with Carboplatin AUC5 once every 3 weeks for 4 cycles and Paclitaxel 80 mg/m^2 every week for 12 weeks.12 weeks of concurrent treatment will immediately followed by Nivolumab monotherapy 240 mg IV. Surgery will follow treatment a minimum of 2 weeks and a maximum of 4 weeks later after the last dose of paclitaxel.The two arms are being compared and one arm does not act as a control to the other. pCR rate will be assessed separately in each cohort. Cancer Australia demographic data has been collected including: Postcode of usual residence, Indigenous Status, CALD status (Country of Birth, Main language other than English used as the principle means of communication). COHORT C. THIS DATASET IS NOT YET AVAILABLE FOR DATA SHARING. Dataset of 54 triple negative breast cancer patients in a single arm Phase II study to look at if the addition of relatlimab may further increase the pCR rate with a 12 week chemotherapy combination. ARM C - Nivolumab 240 mg + relatlimab 240 mg (fixed dose combination) IV D1 lead in window dose, and 2 weeks later followed by nivolumab + relatlimab 360 mg (fixed dose combination) IV D1 Q3W x 4 with carboplatin AUC1.5 and paclitaxel D1 80mg/m2 weekly x 12 as an IV infusion administered per institutional guidelines. Surgery will be performed 14-28 days after the last paclitaxel dose. Cancer Australia demographic data has been collected including: Postcode of usual residence, Indigenous Status, CALD status (Country of Birth, Main language other than English used as the principle means of communication).

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