Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial.

ABSTRACT: Cancer of unknown primary has a dismal prognosis, especially following failure of platinum-based chemotherapy. 10-20% of patients have a high tumor mutational burden (TMB), which predicts response to immunotherapy in many cancer types. In this prospective, non-randomized, open-label, multicenter Phase II trial (EudraCT 2018-004562-33; NCT04131621), patients relapsed or refractory after platinum-based chemotherapy received nivolumab and ipilimumab following TMB^high vs. TMB^low stratification. Progression-free survival (PFS) represented the primary endpoint; overall survival (OS), response rates, duration of clinical benefit and safety were the secondary endpoints. The trial was prematurely terminated in March 2021 before reaching the preplanned sample size (n = 194). Am

SUBMITTER: Pouyiourou M 

PROVIDER: S-EPMC10598029 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature