Abstract

TPS2604Background: Combination D + T is approved for the treatment of BRAF V600E/K–mutant unresectable or metastatic melanoma. BRAF V600E mutations have also been identified in some rare cancers, including anaplastic thyroid cancer, biliary tract cancer, gastrointestinal stromal tumor, nonseminomatous germ cell tumor, hairy cell leukemia (HCL), World Health Organization (WHO) grade I/II glioma, WHO grade III/IV glioma, multiple myeloma, and adenocarcinoma of the small intestine. US incidence rates of these rare tumors range from 0.07 to 6.3 per 100,000, with BRAF V600E mutation frequency ranging from 3% in high-grade glioma to 90% in HCL. Therefore, the ROAR study is underway in pts with these 9 rare BRAF-mutant cancers to assess the safety and efficacy of D + T combination therapy. Methods: This international, multicenter, open-label phase 2 study (NCT02034110) uses a Bayesian hierarchical statistical design that increases study power by borrowing information across histology cohorts based on the emergin...

Full Text
Paper version not known

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call