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

NCT03445533 ↗

Phase 3 Terminated 481 enrolled Idera Pharmaceuticals, Inc. Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2018-05-30
Primary completion: 2021-06-01
Completion: 2021-06-01

Outcome

Missed primary endpoint

Stopped: “Lack of Efficacy”

registry analysis (superiority test); Arm A: Ipilimumab vs Arm B: IMO-2125 Plus Ipilimumab; p = 0.9394 NCT03445533 ↗

registry analysis (superiority test); Arm A: Ipilimumab vs Arm B: IMO-2125 Plus Ipilimumab; p = 0.6775; Cox Proportional Hazard 0.955 (95% CI 0.770 to 1.186) NCT03445533 ↗

paper Combining IT tilsotolimod with ipilimumab did not significantly improve the ORR or OS compared with ipilimumab alone PMID 40048691 ↗

Publications

Diab A, Ascierto PA, Maio M, Abdel-Wahab R, Negrier S, Mortier L, Arenberger P, Dalle S, Krajsova I, de la Cruz L, Leccia MT, Guida M, Lebbe C, Grob JJ, Butler MO, In GK, Loquai C, Walker JWT, Atkinson V, Kapiteijn E, Haferkamp S, Chunduru S, Rahimian S, Guidoboni M, Robert C. Randomized, Open-Label, Phase III Study of Tilsotolimod in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced Refractory Melanoma (ILLUMINATE-301). J Clin Oncol. 2025 May 20;43(15):1800-1809. doi: 10.1200/JCO.24.00727. Epub 2025 Mar 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Tilsotolimod	Unknown	—	Other