An Analysis of the Clinical Trial Landscape for Cutaneous Melanoma
Recognizing current trends and obstacles in melanoma clinical trial development is critical to future progress in this field. This article examines the melanoma research enterprise to identify changing trends and potential barriers to success. All trials registered at ClinicalTrials.gov after September 2005 were evaluated for possible inclusion. A total of 777 interventional trials designed specifically for cutaneous melanoma patients were included. Geographic trial distribution as well as disease state and type of intervention were analyzed and compared among each group. ClinicalTrials.gov is an invaluable tool to study the research enterprise. Further studies are needed on prevention and early detection of melanoma in the curative setting, a critical role for dermatologists.
Practice Points
- The landscape of melanoma clinical trial research has shifted to follow advances in targeted therapy and immunotherapy.
- With these new treatments there is an increased risk for nonmelanoma skin toxicities requiring increased vigilance and collaboration between dermatologists and oncologists.
- Physicians are encouraged to use ClinicalTrials.gov to find details and contact information for actively recruiting clinical trials and results on completed trials.
Our study also highlights the dynamic nature of the field. For example, novel vaccine therapies have demonstrated promise in the metastatic/ unresectable tumor setting, with some herpes simplex virus–based vaccines generating durable antitumor immune responses in patients with melanoma.21 Combination therapy with CTLA-4 and PD-1 inhibitors has demonstrated improved objective response rates and progression-free survival over monotherapy.22 As the status of actively recruiting trials changes on a regular basis, we encourage physicians to access ClinicalTrials.gov to find details and contact information for actively recruiting trials and results on completed trials.
Early detection and management, however, still remain our primary option for cure, and the role of community dermatologists cannot be overstated.23 Patients with stage I and stage II disease have excellent long-term survival rates, yet only 6% of all clinical trials in cutaneous melanoma have focused on patient education, disease prevention, early detection, and local management. With an increasing incidence of melanoma among an aging population, the disease burden remains of substantial concern.24 Optimizing disease prevention, appropriate screening, and early detection are critical roles for dermatologists.
Finally, our data offer some insight into accrual barriers often faced by clinical trials. Actively enrolling clinical trials cluster within major metropolitan areas, presumably with large academic medical centers; however, areas in the southwestern United States and Florida, for example, have some of the highest burden of disease, likely secondary to sun exposure and aging populations.25 Integration of community dermatologists and oncologists may decrease both actual and patient-perceived barriers to care, which requires further exploration.6
Conclusion
Melanoma incidence and disease burden is increasing, and the field of melanoma research is incredibly dynamic. Going forward, we believe dermatologists will continue to play a critical role both in primary disease prevention and detection as well as in detection of secondary treatment-related skin toxicities. ClinicalTrials.gov is an invaluable resource to keep interested parties informed, foster collaboration, identify potential barriers to success, and suggest future directions.
