Spots Global Cancer Trial Database for Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma

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Trial Identification

Brief Title: Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma

Official Title: Phase II Study of PD-1 Inhibitor Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma

Study ID: NCT05130177

Conditions

Melanoma

Interventions

Zimberelimab

Domvanalimab

Study Description

Brief Summary: The main goal of this study is to establish the proportion of patients with objective response to zimberelimab/domvanalimab in PD-1 R/R melanoma patients.

Detailed Description: This is a single-arm two-stage phase II study of PD-1 inhibitor zimberelimab (AB122) in combination with TIGIT inhibitor domvanalimab (AB154) in advanced melanoma patients who have failed PD-1 inhibitor therapy. Patients will undergo a 28-day screening evaluation consisting of systemic staging scans, tumor biopsy, and blood studies to confirm suitability. Once enrolled, patients will receive zimberelimab 360 mg every 3 weeks (Q3W) and domvanalimab 15 mg/kg Q3W. Patients will undergo restaging scans at W9 following 3 cycles of therapy with response assessed using RECIST v1.1 and iRECIST. Following restaging scans, patients with response will continue to receive zimberelimab and domvanalimab till disease progression, intolerable toxicity or for up to 24 months.