Wednesday, March 14, 2018 CCTG IND.225 is a phase II study of the assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker, is closed to accrual. Although the trial is closed accrual, treatment and follow up of patients will continue according to the protocol. For more information contact Study Coordinator Linda Hagerman A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker Complexity Level: 2 Eligibility: Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery. Clinically and/or radiologically documented disease. ECOG 0-1. No prior systemic therapy for metatatic melanoma. No known history of HIV. Patients with active autoimmune disease that requires systemic steroids or immunosuppressive agents are not eligible. Patients with a history of malignancy within 5 years prior to first study drug administration are not eligible. Patients with an allergy to iodinated contrast media used for CT and patients with known history of active TB are not eligible. Objectives: Primary Objective: to determine if tumour texture measures derived from CT correlates with response. Secondary Objectives: to determine if tumour texture measures derived from CT correlated with time to disease progression; to assess duration of response; to assess overall response rate; to assess overall survival; to compare QALY between pembrolizumab and dacarbazine; to compare QALY between pembrolizumab and ipilimumab; toxicity using CTCAE v4.
