Phase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naïve patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B).
Phase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naïve patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B).
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DOI：
10.1136/jitc-2022-004780
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发表时间：
2023-03
影响因子：
10.9
通讯作者：
中科院分区：
文献类型：
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作者：
To determine the efficacy and toxicity of nivolumab monotherapy in treatment-naïve patients with non-clear cell renal cell carcinoma (nccRCC) and the efficacy of nivolumab/ipilimumab salvage therapy in patients with tumors unresponsive to initial nivolumab monotherapy. Eligible patients with treatment-naïve nccRCC received nivolumab until progressive disease (PD), toxicity, or completion of 96 weeks of treatment (Part A). Patients with PD prior to, or stable disease (SD) at 48 weeks (prolonged SD) were potentially eligible to receive salvage nivolumab/ipilimumab (Part B). Patients were required to submit tissue from a metastatic lesion obtained within 12 months prior to study entry and prior to Part B for correlative studies. 35 patients with nccRCC were enrolled: 19 (54%) had papillary, 6 (17%) had chromophobe and 10 (29%) had unclassified histology. At median follow-up of 22.9 months, RECIST-defined objective response rate (ORR) was 5 of 35 (14.3% 95% CI 4.8% to 30.3%) (complete response (CR) 2 (5.7%) and partial response (PR) 3 (8.6%)). ORR by histology was: papillary—1/19 (5%); chromophobe—1/6 (17%); and unclassified—3/10 (30%). Nine patients (26%) had tumors with sarcomatoid features with 3 (33%) (2 unclassified and 1 papillary) responding. ORR was 0/18, 3/11 (27%) and 2/6 (33%) for patients with tumor progammed death ligand 1 (PD-L1) expression of <5%, ≥5% or not measured, respectively. Median progression-free survival was 4.0 (2.7–4.3) months. Two of five responders have progressed. Thirty-two patients had PD or prolonged SD and therefore, were potentially eligible for salvage nivolumab/ipilimumab (Part B), but 15 patients did not enroll due to grade 2–3 toxicity (6) on nivolumab, symptomatic disease progression (5), or other reasons including no biopsy tissue (4). In the 17 Part B patients, there was one PR (6%) (unclassified/non-sarcomatoid). Grade >3 treatment-related adverse events were seen in 7/35 (20%) on nivolumab and 7/17 (41%) on salvage nivolumab/ipilimumab with one patient experiencing sudden death. Nivolumab monotherapy has limited activity in treatment-naïve nccRCC with most responses (4 of 5) seen in patients with sarcomatoid and/or unclassified tumors. Toxicity is consistent with prior nivolumab studies. Salvage treatment with nivolumab/ipilimumab was provided in half of these patients with minimal activity. NCT03117309.
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DOI：
10.1016/s0140-6736(21)00152-5
发表时间：
2021-02-20
期刊：
Lancet (London, England)
影响因子：
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作者：
Pal SK;Tangen C;Thompson IM Jr;Balzer-Haas N;George DJ;Heng DYC;Shuch B;Stein M;Tretiakova M;Humphrey P;Adeniran A;Narayan V;Bjarnason GA;Vaishampayan U;Alva A;Zhang T;Cole S;Plets M;Wright J;Lara PN Jr
通讯作者：
Lara PN Jr
DOI：
10.1200/jco.20.02363
发表时间：
2021-03-20
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
McDermott DF;Lee JL;Bjarnason GA;Larkin JMG;Gafanov RA;Kochenderfer MD;Jensen NV;Donskov F;Malik J;Poprach A;Tykodi SS;Alonso-Gordoa T;Cho DC;Geertsen PF;Climent Duran MA;DiSimone C;Silverman RK;Perini RF;Schloss C;Atkins MB
通讯作者：
Atkins MB
DOI：
10.1200/jco.20.02365
发表时间：
2021-03-20
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
McDermott DF;Lee JL;Ziobro M;Suarez C;Langiewicz P;Matveev VB;Wiechno P;Gafanov RA;Tomczak P;Pouliot F;Donskov F;Alekseev BY;Shin SJ;Bjarnason GA;Castellano D;Silverman RK;Perini RF;Schloss C;Atkins MB
通讯作者：
Atkins MB
影响因子：
28.4
作者：
Rimm DL;Han G;Taube JM;Yi ES;Bridge JA;Flieder DB;Homer R;West WW;Wu H;Roden AC;Fujimoto J;Yu H;Anders R;Kowalewski A;Rivard C;Rehman J;Batenchuk C;Burns V;Hirsch FR;Wistuba II
通讯作者：
Wistuba II
晚期肾细胞癌中 Nivolumab 和 Ipilimumab 的优化治疗：基于反应的 II 期研究 (OMNIVORE)
影响因子：
45.3
作者：
McKay, Rana R.;McGregor, Bradley A.;Choueiri, Toni K.
通讯作者：
Choueiri, Toni K.