Pembrolizumab Trial for Advanced Melanoma Reaches Primary Completion

The Phase 3 clinical trial investigating IO102-IO103 in combination with pembrolizumab (Keytruda) for advanced melanoma reached its primary completion on 2025-05-30. This multicenter, international study, known as IOB-013 / KN-D18 (NCT05155254), enrolled 407 participants to evaluate the safety and efficacy of the combination therapy as a first-line treatment.

Background

Pembrolizumab is an established immunotherapy used in the treatment of various cancers, including melanoma. This trial specifically focuses on its use in patients with unresectable or metastatic (advanced) melanoma, a serious form of skin cancer where effective treatment options are critical.

Trial design

The IOB-013 / KN-D18 study (NCT05155254) is a Phase 3, multicenter, international, open-label, randomized, 2-arm trial. It enrolled 407 participants with previously untreated unresectable or metastatic (advanced) melanoma. Patients were stratified based on disease stage (Stage III unresectable and IV M1a-b versus Stage IV M1c-d) and BRAFV600 mutation status (mutated vs wild type).

The trial investigated IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone. All patients received pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). The primary outcomes for this trial have not yet been publicly reported.

What this means

The primary completion of this Phase 3 trial signifies a key milestone in the development process for IO102-IO103 in combination with pembrolizumab for advanced melanoma. While specific efficacy and safety results are not yet available, the completion of the primary data collection phase indicates that the study has progressed as planned. The next steps will involve data analysis and subsequent reporting of the trial's findings, which will provide crucial insights into the potential of this combination therapy as a first-line treatment for patients with unresectable or metastatic melanoma.

Source

The information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT05155254, titled "IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)," was updated on 2025-05-30 on clinicaltrials.gov.