PT - JOURNAL ARTICLE AU - Vadim S. Koshkin AU - Pedro C. Barata AU - Tian Zhang AU - Daniel J. George AU - Michael B. Atkins AU - William J. Kelly AU - Nicholas J. Vogelzang AU - Sumanta K. Pal AU - JoAnn Hsu AU - Leonard J. Appleman AU - Moshe C. Ornstein AU - Timothy Gilligan AU - Petros Grivas AU - Jorge A. Garcia AU - Brian I. Rini TI - Clinical activity of nivolumab in patients with non-clear cell renal cell carcinoma AID - 10.1186/s40425-018-0319-9 DP - 2018 Dec 01 TA - Journal for ImmunoTherapy of Cancer PG - 9 VI - 6 IP - 1 4099 - http://jitc.bmj.com/content/6/1/9.short 4100 - http://jitc.bmj.com/content/6/1/9.full SO - J Immunother Cancer2018 Dec 01; 6 AB - Background Nivolumab is approved for patients with metastatic renal cell carcinoma (mRCC) refractory to prior antiangiogenic therapy. The clinical activity of nivolumab in patients with non-clear cell RCC subtypes remains unknown as these patients were excluded from the original nivolumab trials.Methods Patients from 6 centers in the United States who received at least one dose of nivolumab for non-clear cell mRCC between 12/2015 and 06/2017 were identified. A retrospective analysis including patient characteristics, objective response rate according to RECIST v1.1 and treatment-related adverse events (TRAEs) was undertaken.Results Forty-one patients were identified. Median age was 58 years (33–82), 71% were male, and majority had ECOG PS 0 (40%) or 1 (47%). Histology included 16 papillary, 14 unclassified, 5 chromophobe, 4 collecting duct, 1 Xp11 translocation and 1 MTSCC (mucinous tubular and spindle cell carcinoma). Among 35 patients who were evaluable for best response, 7 (20%) had PR and 10 (29%) had SD. Responses were observed in unclassified, papillary and collecting duct subtypes. In the entire cohort, median follow-up was 8.5 months and median treatment duration was 3.0 months. Median PFS was 3.5 months and median OS was not reached. Among responders, median time to best response was 5.1 months, and median duration of response was not reached as only 2 out of 7 responders had disease progression during follow-up. TRAEs of any grade were noted in 37% and most commonly included fatigue (12%), fever (10%) and rash (10%). Nivolumab treatments were postponed in 34% and discontinued in 15% of patients due to intolerance. No treatment-related deaths were observed.Conclusions Nivolumab monotherapy demonstrated objective responses and was well tolerated in a heterogeneous population of patients with non-clear cell mRCC. In the absence of other data in this treatment setting, this study lends support to the use of nivolumab for patients with metastatic non-clear cell renal cell carcinoma.Abbreviations:ccRCCclear cell renal cell carcinomaICIImmune checkpoint inhibitorsIMDCInternational Metastatic Renal Cell Carcinoma Database ConsortiummRCCmetastatic renal cell carcinomaMTSCCMucinous tubular and spindle cell carcinomanon-ccRCCnon-clear cell renal cell carcinomaORRObjective response rateOSOverall survivalPDProgressive diseasePFSProgression free survivalRECISTResponse Evaluation Criteria in Solid TumorsSDStable diseaseTIMCsTumor-infiltrating mononuclear cellsTRAEsTreatment-related adverse events