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A phase II study of nivolumab (N) plus ipilimumab (I) in radioidine refractory differentiated thyroid cancer (RAIR DTC) with exploratory cohorts in anaplastic (ATC) and medullary thyroid cancer (MTC).

医学 内科学 甲状腺癌 甲状腺乳突癌 伦瓦提尼 甲状腺髓样癌 甲状腺间变性癌 耐火材料(行星科学) 胃肠病学 临床终点 临床研究阶段 肿瘤科 癌症 临床试验 天体生物学 物理
作者
Jochen H. Lorch,Justine A. Barletta,Matthew A. Nehs,Ravindra Uppaluri,Erik K. Alexander,Robert I. Haddad,Glenn J. Hanna,Danielle N. Margalit,Roy B. Tishler,Jonathan D. Schoenfeld,Laura A. Goguen,Azad Jabiev,Meredith J. Sorensen,Sara Ahmadi,Ellen Marqusee,Matthew I. Kim,Darren Stanizzi,Ethan Harris,Alec J. Kacew,David A. Barbie
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:38 (15_suppl): 6513-6513 被引量:44
标识
DOI:10.1200/jco.2020.38.15_suppl.6513
摘要

6513 Background: Treatment options for aggressive TC are limited. Pre-clinical data suggests efficacy of CTLA-4 plus PD-1 blockade in aggressive RAIR TC. Methods: This investigator initiated phase II study tested N (3mg/kg every 2 weeks) plus I (1mg/kg every 6 weeks) until disease progression or completion of 24 mo of treatment in RAIR differentiated TC including poorly differentiated TC (PDTC) with exploratory cohorts in anaplastic (ATC) and medullary TC (MTC). Radiographic response rate by RECIST v1.1 (CR+PR) was primary endpoint. At least 6 pts with disease response among n=32 DTC provided 84% power to distinguish between a 10% and a 25% RR (one-sided 9% binomial test). Results: Accrual is complete with n=32 patients with DTC, 10 with ATC and 7 with MTC enrolled between October 2017 and May 2019. Thirty-two DTC included: n=17 papillary, n=7 Hurthle, n=4 follicular TC, n=4 PDTC. Among n=49, median (range) age was 65 (30-88), 51% (25/49) were female. To date, in DTC, 3/32 achieved a PR (n=2 Hurthle and n=1 PDTC), 9.4% RR (.95CI:2%-25%). One near complete response has been observed. Among pts w ATC, 3/ 10 profound PR by RECIST occurred (30% RR, .95CI: 7%-65%). Among them, two remain without clear evidence of disease at 26 and 13 mo after treatment start. No PR's were observed in MTC. Most frequent grade 3-4 TRAEs were as expected and included increased lipase (n=8), increased serum amylase (n=4). There was an unexpected number of treatment related adrenal insufficiency (AI) (n=4) which was associated with long PFS (range 10.1—16.4+mo). Conclusions: N+I appears to have considerable activity in ATC. In unselected RAIR DTC, activity was low but responses were seen in PDTC and Hurthle cell TC. Exceptional responses with prolonged remissions were observed. Clinical trial information: NCT03246958 .

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