A Prospective Clinical Trial Combining Radiation Therapy with Systemic Immunotherapy in Metastatic Melanoma
Abstract
Purpose Local radiation therapy (RT) in combination with systemic anti-CTLA-4 immunotherapy may enhance induction of systemic anti-melanoma immune responses. The primary objective of this trial was to assess the safety and efficacy of combining ipilimumab with RT in patients with stage IV melanoma. Secondary objectives included laboratory assessment of induction of anti-melanoma immune responses. Materials/Methods In our prospective clinical trial, 22 patients with stage IV melanoma were treated with palliative RT and ipilimumab for 4 cycles. RT to 1-2 disease sites was initiated within 5 days after starting ipilimumab. Patients had ≥1 nonirradiated metastasis measuring 7≥1.5 cm for response assessment. Tumor imaging studies were obtained at baseline, 2-4 weeks following cycle 4 of ipilimumab, and every 3 months until progression. Laboratory immune response parameters were measured before and during treatment. Results Combination therapy was well-tolerated without unexpected toxicities. Eleven patients (50.0%) had clinical benefit from therapy, including complete and partial responses (CR, PR) and stable disease (SD) at median follow-up of 55 weeks. Three (27.3%) achieved an ongoing systemic CR at median follow-up of 55 weeks (range 32-65), and 3 (27.3%) had initial PR for a median of 40 weeks. Analysis of immune response data suggests a relationship between elevated CD8-activated T-cells and response. Conclusion This is the second prospective clinical trial of treatment of…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 22 participants or records.
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