High-Dose Ipilimumab and High-Dose Interleukin-2 for Patients With Advanced Melanoma. 2019

Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
Department of Medical Oncology, Dana-Farber Cancer Institute and Department of Medicine, Harvard Medical School, Boston, MA, United States.

High-dose ipilimumab (IPI) and high-dose interleukin-2 (IL-2) are approved agents for metastatic melanoma, but the efficacy and safety of the combination are unknown. The objective of this study was to evaluate the feasibility, safety, and efficacy of combination high-dose IPI and high-dose IL-2 in patients with histologically confirmed advanced unresectable stage III and IV melanoma. This Phase II, multicenter, open-label, single-arm trial was conducted in nine patients enrolled between 12/2014 and 12/2015. Subjects were treated with high-dose IPI 10 mg/kg intravenous (IV) every 3 weeks for four doses starting at week 1 and high-dose IL-2 (600,000 IU/kg IV bolus every 8 h for up to 14 doses) concurrently with IPI at weeks 4 and 7. After the first 12 weeks of combination therapy, maintenance IPI (10 mg/kg IV) monotherapy was administered every 12 weeks for up to 1 year. No patient had received prior PD-1 blockade, and only one received prior vemurafenib. Confirmed partial response was achieved in one (11%), stable disease in four (44%), and progressive disease in four (44%) of nine patients. Two patients achieved durable disease control of 44+ and 50+ months at the most recent follow-up without subsequent therapy. The median overall survival was not reached after a minimum 24 months of follow-up time. One-year and 2-year survival rates were 89 and 67%, respectively. Seven patients (78%) experienced grade 3 or 4 adverse events related to the study therapy, three of which were attributed to both agents. One patient discontinued the treatment due to liver and kidney toxicity. While toxicity was significant, all events were reversible, and there was no treatment-related mortality. In peripheral blood of patients with decreasing tumor burden, the ratio of the non-classical MHC-II proteins HLA-DM to HLA-DO increased 2-fold, raising the possibility of the ratio of HLA-DM:HLA-DO as a novel biomarker of response to treatment. Although the sample size was limited, combination therapy with high-dose IPI and high-dose IL-2 was feasible and associated with clinical benefit. IL-2-based compounds in combination with CTLA-4 blockade should be studied in advanced melanoma patients who fail to benefit from first-line PD-1 blockade. Clinical Trial Registration: ClinicalTrials.gov, NCT02203604. Registered 30 July 2014, https://clinicaltrials.gov/ct2/show/NCT02203604.

UI MeSH Term Description Entries

Related Publications

Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
September 2016, Oncotarget,
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
June 2013, The oncologist,
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
September 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology,
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
January 2016, Journal for immunotherapy of cancer,
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
August 1992, Lancet (London, England),
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
December 2015, European journal of cancer (Oxford, England : 1990),
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
May 2000, Cancer,
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
March 2021, Clinical cancer research : an official journal of the American Association for Cancer Research,
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
August 2012, Expert opinion on biological therapy,
Ann W Silk, and Howard L Kaufman, and Brendan Curti, and Janice M Mehnert, and Kim Margolin, and David McDermott, and Joseph Clark, and Jenna Newman, and Praveen K Bommareddy, and Lisa Denzin, and Saltanat Najmi, and Azra Haider, and Weichung Shih, and Michael P Kane, and Andrew Zloza
June 2012, BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy,
Copied contents to your clipboard!