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Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial.
Tykodi, Scott S; Gordan, Lucio N; Alter, Robert S; Arrowsmith, Edward; Harrison, Michael R; Percent, Ivor; Singal, Rakesh; Van Veldhuizen, Peter; George, Daniel J; Hutson, Thomas; Zhang, Joshua; Zoco, Jesus; Johansen, Jennifer L; Rezazadeh Kalebasty, Arash.
Affiliation
  • Tykodi SS; Division of Medical Oncology, University of Washington, Seattle, Washington, USA stykodi@fredhutch.org.
  • Gordan LN; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
  • Alter RS; Florida Cancer Specialists, Gainesville, Florida, USA.
  • Arrowsmith E; John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
  • Harrison MR; Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Chattanooga, Tennessee, USA.
  • Percent I; Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, North Carolina, USA.
  • Singal R; Florida Cancer Specialists, Port Charlotte, Florida, USA.
  • Van Veldhuizen P; Sylvester Comprehensive Cancer Center, Miami, Florida, USA.
  • George DJ; Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
  • Hutson T; Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, North Carolina, USA.
  • Zhang J; Texas A&M University College of Medicine, Bryan, Texas, USA.
  • Zoco J; Department of Clinical Research, Bristol Myers Squibb, Princeton, New Jersey, USA.
  • Johansen JL; Syneos Health, Braine l'Alleud, Belgium.
  • Rezazadeh Kalebasty A; US Medical Immunology & Fibrosis, Bristol Myers Squibb, Princeton, New Jersey, USA.
J Immunother Cancer ; 10(2)2022 02.
Article in En | MEDLINE | ID: mdl-35210307
BACKGROUND: CheckMate 920 (NCT02982954) is a multicohort, phase 3b/4 clinical trial of nivolumab plus ipilimumab treatment in predominantly US community-based patients with previously untreated advanced renal cell carcinoma (RCC) and clinical features mostly excluded from phase 3 trials. We report safety and efficacy results from the advanced non-clear cell RCC (nccRCC) cohort of CheckMate 920. METHODS: Patients with previously untreated advanced/metastatic nccRCC, Karnofsky performance status ≥70%, and any International Metastatic Renal Cell Carcinoma Database Consortium risk received up to four doses of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks followed by nivolumab 480 mg every 4 weeks for ≤2 years or until disease progression/unacceptable toxicity. The primary endpoint was incidence of grade ≥3 immune-mediated adverse events (AEs) within 100 days of last dose of study drug. Key secondary endpoints included objective response rate (ORR), progression-free survival (PFS; both investigator-assessed), time to response (TTR), and duration of response (DOR), all using RECIST V.1.1. Overall survival (OS) was exploratory. RESULTS: Fifty-two patients with nccRCC (unclassified histology, 42.3%; papillary, 34.6%; chromophobe, 13.5%; translocation-associated, 3.8%; collecting duct, 3.8%; renal medullary, 1.9%) received treatment. With 24.1 months minimum study follow-up, median duration of therapy (range) was 3.5 (0.0-25.8) months for nivolumab and 2.1 (0.0-3.9) months for ipilimumab. Median (range) number of doses received was 4.5 (1-28) for nivolumab and 4.0 (1-4) for ipilimumab. Grade 3-4 immune-mediated AEs were diarrhea/colitis (7.7%), rash (5.8%), nephritis and renal dysfunction (3.8%), hepatitis (1.9%), adrenal insufficiency (1.9%), and hypophysitis (1.9%). No grade 5 immune-mediated AEs occurred. ORR (n=46) was 19.6% (95% CI 9.4 to 33.9). Two patients achieved complete response (papillary, n=1; unclassified, n=1), seven achieved partial response (papillary, n=4; unclassified, n=3), and 17 had stable disease. Median TTR was 2.8 (range 2.1-14.8) months. Median DOR was not reached (range 0.0+-27.8+); eight of nine responders remain without reported progression. Median PFS (n=52) was 3.7 (95% CI 2.7 to 4.6) months. Median OS (n=52) was 21.2 (95% CI 16.6 to not estimable) months. CONCLUSIONS: Nivolumab plus ipilimumab for previously untreated advanced nccRCC showed no new safety signals and encouraging antitumor activity. TRIAL REGISTRATION NUMBER: NCT02982954.
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Full text: 1 Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Ipilimumab / Nivolumab / Kidney Neoplasms Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: J Immunother Cancer Year: 2022 Type: Article Affiliation country: United States

Full text: 1 Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Ipilimumab / Nivolumab / Kidney Neoplasms Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: J Immunother Cancer Year: 2022 Type: Article Affiliation country: United States