Spots Global Cancer Trial Database for Durvalumab and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors

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Trial Identification

Brief Title: Durvalumab and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors

Official Title: Phase 2 Investigation of MEDI4736 (Durvalumab) and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors

Study ID: NCT03911557

Conditions

Tumor, Solid

Interventions

Durvalumab and Tremelimumab

Study Description

Brief Summary: This study will examine whether patients with relapsed/refractory solid tumors harboring evidence of somatic hypermutation (intermediate versus high tumor mutational burden) will exhibit improvement in disease progression-free survival with dual Tremelimumab and Durvalumab treatment.

Detailed Description: This study is phase II basket trial to evaluate the benefit of immunotherapy (Durvalumab and Tremelimumab combination) in treatment of relapse/refractory solid tumor patients whose tumors express a high tumor mutational burden (TMB high \>20 mutations/MB) or moderate tumor mutational burden (10-20 mutations/MB) as based on next generation sequencing (NGS). The primary endpoint of the study is the TTP (time-to-progression) ratio or growth modulation index (GMI) which is defined for individual patients as the ratio of their TTP on the current therapy to their TTP on the most recent previous therapy.