NCT05533697

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 361 (estimated)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-4359	Intramuscular Injection
BIOLOGICAL	Pembrolizumab	Intravenous infusion
BIOLOGICAL	Ipilimumab	Intravenous infusion
BIOLOGICAL	Nivolumab	Intravenous infusion

Timeline

• Start date: 2022-09-01
• Primary completion: 2032-02-18
• Completion: 2032-02-18
• First posted: 2022-09-09
• Last updated: 2026-04-03

Locations

28 sites across 4 countries: United States, Australia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study