Endpoints and assessments
death, Tumor, immune-mediated adverse, DMFS, primary melanomas, primary melanoma, Cancer
ADVERSE EVENT, RECURRENCE, TUMOR, ADVERSE EVENTS, EVENT, DISEASE, MELANOMA IN SITU, SECONDARY, EVENTS, EVENTS, CANCER
The primary endpoint for the trial was investigator-assessed RFS, defined as the time between randomization and the first recurrence event. Events included local, regional or distant recurrence; new primary melanomas (including in situ); and death due to any cause. Patients could continue on blinded adjuvant treatment with a diagnosis of melanoma in situ but not with an invasive new primary melanoma. Imaging was required every 26 weeks for the first 3 years and annually in years 4 and 5. Tumor assessments were performed using contrast-enhanced computed tomography of the chest, abdomen, pelvis and all other relevant sites based on known or suspected disease sites (slice thickness ≤5 mm, with no intervening gaps). Cytological and/or histological evidence of recurrence was required in all cases unless a biopsy was deemed to be clinically unsafe or not feasible by the investigator.Secondary efficacy endpoints included DMFS (presented here), defined as the time between randomization and first distant recurrence or death due to any cause, as well as OS and progression-free survival through next-line therapy (follow-up is ongoing, and those results are not presented here). The secondary endpoint of safety for the blinded phase of the trial is presented here for treatment-related adverse events ≤30 d after the last dose of study therapy as well as for immune-mediated adverse events (non-endocrine events requiring immunomodulators and endocrine events, regardless of immune-modulating treatment) ≤100 d after the last dose of study therapy. Time to onset and resolution data are also presented for immune-mediated adverse events. Occurrences and severity of adverse events were defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 Exploratory health-related quality of life and tissue-based biomarker analyses, including those by PD-L1 expression, are ongoing.