Across 95 Phase II–III melanoma trial records authorized in CTIS from 2024–2026, site activity is concentrated in a small group of high-repeat European melanoma hubs. Phase II-containing records represented 62/95 trials (65.3%), while Phase III records represented 33/95 trials (34.7%). The strongest site signal was Institut Gustave Roussy with 14 observed site participations, followed by IRCCS Istituto Nazionale Tumori Fondazione Pascale with 12 and Narodowy Instytut Onkologii with 11.
The top 10 sites accounted for 104 site participations across the 95-trial melanoma dataset. France, Italy, Germany, Spain, and Poland dominate the highest-repeat site list, reflecting the operational importance of large academic melanoma centers with dedicated dermatology-oncology or immunotherapy units.
The European melanoma site landscape is not evenly distributed. A small group of recurring academic centers appears repeatedly across immunotherapy, adjuvant, metastatic, and biomarker-defined melanoma trials, making them high-value sites for feasibility, investigator engagement, and competitive enrollment planning.
Spain, France, and Germany formed the strongest country-level allocation cluster, together accounting for 3,034 planned participant allocations among the top 10 countries. Spain led with 1,168 allocations, followed by France with 1,040 and Germany with 826.
| Rank | Country | Participants | Share of top 10 |
|---|---|---|---|
| 1 | Spain | 1,168 | 21.2% |
| 2 | France | 1,040 | 18.9% |
| 3 | Germany | 826 | 15.0% |
| 4 | Italy | 694 | 12.6% |
| 5 | Poland | 410 | 7.4% |
| 6 | Netherlands | 362 | 6.6% |
| 7 | Belgium | 310 | 5.6% |
| 8 | Austria | 269 | 4.9% |
| 9 | Greece | 257 | 4.7% |
| 10 | Ireland | 181 | 3.3% |
Spain’s high allocation signal is driven by broad multi-site national participation, while France and Germany combine high participant allocation with repeat appearance of specialized melanoma centers. For sponsor feasibility, this suggests that country-level capacity and site-level concentration should be assessed separately.
Phase II-containing records represented 62/95 trials (65.3%), while Phase III represented 33/95 trials (34.7%). By authorization year, 2024 accounted for 68/95 records (71.6%), compared with 18/95 in 2025 (18.9%) and 9/95 in 2026 (9.5%).
The dataset is weighted toward Phase II and Phase II/III development rather than purely confirmatory Phase III activity. This pattern is consistent with melanoma’s active experimental landscape, where many protocols test new immunotherapy combinations, targeted regimens, or biomarker-selected concepts before large confirmatory expansion.
Advanced, unresectable, or metastatic melanoma was the dominant disease segment with 51/95 records (53.7%). Earlier-stage cutaneous melanoma, mainly stage II–III adjuvant or resectable settings, accounted for 18/95 records (18.9%), while uveal melanoma represented 8/95 records (8.4%).
Melanoma trial operations remain primarily anchored in advanced disease, but the presence of stage II–III adjuvant records shows continued movement into earlier disease settings. Uveal melanoma appears as a distinct specialist segment, likely requiring more selective site networks than mainstream cutaneous melanoma.
Monoclonal antibody and checkpoint-inhibitor-based approaches dominated the modality mix with 58/95 records (61.1%). Small molecule or targeted therapy records represented 22/95 (23.2%), while cell/gene/viral approaches remained a smaller but visible group at 6/95 records (6.3%).
The operational center of gravity remains immuno-oncology. Sites with dermatology-oncology infrastructure, checkpoint inhibitor experience, immune-toxicity management, and biomarker workflow capacity are likely to remain preferred partners for melanoma feasibility.
Phase II-containing records include Phase II and mixed Phase I/II or Phase II/III records captured in the Phase II cohort. Phase III records include records captured in the Phase III cohort. Site participation means the appearance of a site as an active listed trial site in a trial geography record; it is not the same as enrolled-patient count. Participant allocation refers to the country-level planned number of participants recorded in the trial geography variable.