NCT03445533

A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma

A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 481 (actual)
• Sponsor: Idera Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

Detailed description

A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on anti-PD-1

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.
DRUG	Tilsotolimod with Ipilimumab	IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod

Timeline

• Start date: 2018-05-30
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2018-02-26
• Last updated: 2022-11-08
• Results posted: 2022-11-08

Locations

80 sites across 11 countries: United States, Australia, Canada, Czechia, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study