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A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in Braf-V600 Mutant Melanoma with Brain Metastases
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
To estimate the overall survival (OS) of participants in each treatment arm. To estimate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial responses) per RECIST 1.1 in each treatment arm. c. To estimate the intracranial response rate (ICRR), defined as confirmed and unconfirmed complete and partial response per modified RECIST for brain metastases (mRECIST) as defined in Section 10.4. In addition, the ICRR as defined by modified RANO-BM and iRANO (by centralized review) will also be estimated.To evaluate the duration of response, per RECIST 1.1 and the duration of ICRR per mRECIST, and per RANO-BM (and iRANO) in each treatment arm. To evaluate the toxicity profile of each treatment arm. To evaluate current and emerging radiographic response criteria (modified RECIST 1.1, modified RANO-BM and iRANO) by a retrospective blinded independent centralized review (BICR) of banked images.
BMS-936558 (Nivolumab); Binimetinib (); Encorafenib (); Ipilimumab (); Nivolumab (Opdivo); Yervoy (Ipilimumab)
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