Diab, Adi and Ascierto, Paolo A. and Maio, Michele and Abdel-Wahab, Reham and Negrier, Sylvie and Mortier, Laurent and Arenberger, Petr and Dalle, Stephane and Krajsova, Ivana and de la Cruz, Luis and Leccia, Marie-Therese and Guida, Michele and Lebbe, Celeste and Grob, Jean-Jacques and Butler, Marcus O. and In, Gino K. and Loquai, Carmen and Walker, John W. T. and Atkinson, Victoria and Kapiteijn, Ellen and Haferkamp, Sebastian and Chunduru, Srinivas and Rahimian, Shahram and Guidoboni, Massimo and Robert, Caroline (2025) Randomized, Open-Label, Phase III Study of Tilsotolimod in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced Refractory Melanoma (ILLUMINATE-301). JOURNAL OF CLINICAL ONCOLOGY, 43 (15). ISSN 0732-183X, 1527-7755
Full text not available from this repository. (Request a copy)Abstract
PURPOSEThere are limited treatment options for advanced melanoma that have progressed during or after immune checkpoint inhibitor therapy. Intratumoral (IT) immunotherapy may improve tumor-specific immune activation by promoting local tumor antigen presentation while avoiding systemic toxicities. The phase 3 ILLUMINATE-301 study (ClinicalTrials.gov identifier: NCT03445533) evaluated tilsotolimod, a Toll-like receptor-9 agonist, with or without ipilimumab in patients with anti-PD-1 advanced refractory melanoma.METHODSPatients with unresectable stage III-IV melanoma that progressed during or after anti-PD-1 therapy were randomly assigned 1:1 to receive 24 weeks of tilsotolimod plus ipilimumab or 10 weeks of ipilimumab alone. Nine IT injections of tilsotolimod were administered to a single designated lesion over 24 weeks. Intravenous ipilimumab 3 mg/kg was administered once every 3 weeks from week 2 in the tilsotolimod arm and week 1 in the ipilimumab arm. The primary end point was efficacy measured using objective response rate (ORR; independent review) and overall survival (OS).RESULTSA total of 481 patients received tilsotolimod plus ipilimumab (n = 238) or ipilimumab alone (n = 243). ORRs were 8.8% in the tilsotolimod arm and 8.6% in the ipilimumab arm, with disease control rates of 34.5% and 27.2%, respectively. Median OS was 11.6 months in the tilsotolimod arm and 10 months in the ipilimumab arm (hazard ratio, 0.96 [95% CI, 0.77 to 1.19]; P = .7). Grade >= 3 treatment-emergent adverse events occurred in 61.1% and 55.5% of patients in the tilsotolimod and ipilimumab arms, respectively.CONCLUSIONCombining IT tilsotolimod with ipilimumab did not significantly improve the ORR or OS compared with ipilimumab alone in patients with anti-PD-1 advanced refractory melanoma.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | RECEPTOR 9 AGONISTS; TOLL-LIKE-RECEPTOR-9; EFFICACY; THERAPY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 30 Mar 2026 09:22 |
| Last Modified: | 30 Mar 2026 09:22 |
| URI: | https://pred.uni-regensburg.de/id/eprint/67929 |
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