Sponsor: Alliance for Clinical Trials in Oncology
Sponsor Study ID: A092105
Study Title: Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy
CTO #: 103992
NCT Number: NCT05904080
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lip, Oral Cavity and Pharynx
Study Objectives: To determine if the progression-free survival (PFS) of the triplet combination (CaboNivoIpi) is more favorable than the doublet (NivoIpi). To compare safety and tolerability between the two arms (CTCAE v5.0.). To compare overall response rate (ORR) between the two arms via both RECIST v1.1 and iRECIST criteria. To compare overall survival (OS) between the two arms.To assess response by primary or acquired PD-1/L1 inhibitor resistance in the prior line of therapy.