Standardization Arrives for Neoadjuvant Trials in Melanoma
Source: Cancer Network, September 2019
The International Neoadjuvant Melanoma Consortium (INMC) recently published a comprehensive set of recommendations for the design and implementation of clinical trials that aim to assess neoadjuvant therapy in high-risk resectable melanoma patients in Lancet Oncology.
Although neoadjuvant therapy is the standard of care for several cancer types, it is only emerging as a potential approach for high-risk resectable melanoma patients. This set of recommendations could help standardize neoadjuvant clinical trial methodology and develop a path for regulatory review and approval of neoadjuvant therapies in melanoma. The INMC detailed a slew of recommendations for a variety of areas, including patient selection, duration of neoadjuvant and adjuvant treatment, trial endpoints, and biospecimen collection.
In terms of patient selection, the INMC “generally” recommended the inclusion of only patients with clinically measurable and surgically resectable stage III disease. Patients with resectable in-transit metastases or oligometastatic stage IV melanoma and borderline-resectable disease may be included in a trial, but only as a separate cohort. The INMC also recommended the duration of neoadjuvant therapy to last between 6 and 8 weeks and adjuvant therapy to last 1 year.