NCT05130177

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Diwakar Davar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Zimberelimab	Zimberelimab is a fully human immunoglobulin G4 (hIgG4) monoclonal antibody (mAb) that targets the human programmed cell death-1 (PD-1) immune checkpoint.
DRUG	Domvanalimab	Domvanalimab is a humanized immunoglobulin G1 (IgG1) mAb that targets immune checkpoint TIGIT.

Timeline

• Start date: 2022-03-16
• Primary completion: 2026-02-06
• Completion: 2030-01-31
• First posted: 2021-11-23
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study