Young Kwang Chae, Richard Duan, Liam Il-Young Chung, Youjin Oh, Borislav Alexiev, Sangwon Shin, Sukjun Kim, Irene Helenowski, Maria Matsangou, Victoria Villaflor, Devalingam Mahalingam
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The primary endpoint was median progression-free survival (PFS); secondary endpoints were overall response rate (ORR), overall survival (OS), and toxicity.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Patient enrollment was prematurely terminated due to funding constraints. In total, 19 patients with ACC and 5 patients with non-ACC SGC were enrolled. The patients with ACC had a median OS of 30.0 months (95% CI 15.3-NR months), a median PFS of 8.3 months (95% CI 5.5–30.0 months), and a disease control rate (DCR) of 53% (10/19). The ORR in the ACC group was 5% (CR 0%, <i>n</i> = 0; confirmed PR 5%, <i>n</i> = 1), with one patient having continued stable disease at the time of trial conclusion. The patients with non-ACC SGC had a median OS of 10.4 months (95% CI 6.21-NR months), a median PFS of 6.21 months (95% CI 2.83-NR months), and a DCR of 40% (2/5). The ORR in this cohort was 0%.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>In patients with recurrent or metastatic ACC and non-ACC SGC, the combination of nivolumab with ipilimumab resulted in moderate disease control. Further studies are warranted to validate our findings.</p>\n \n <p>Trial number: NCT03146650.</p>\n </section>\n </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 7","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.70724","citationCount":"0","resultStr":"{\"title\":\"Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma (ACC) of all Anatomic Sites of Origin and Other Malignant Salivary Gland Tumors\",\"authors\":\"Young Kwang Chae, Richard Duan, Liam Il-Young Chung, Youjin Oh, Borislav Alexiev, Sangwon Shin, Sukjun Kim, Irene Helenowski, Maria Matsangou, Victoria Villaflor, Devalingam Mahalingam\",\"doi\":\"10.1002/cam4.70724\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>Dual checkpoint inhibitor therapy with nivolumab and ipilimumab has been FDA approved for a number of cancer sites. However, its role in the treatment of ACC and non-ACC salivary gland carcinomas (non-ACC SGC) is not well established.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods and Analysis</h3>\\n \\n <p>We performed Simon's two-stage prospective single-institution Phase II clinical trial of nivolumab with ipilimumab. Two cohorts were analyzed: patients with metastatic/recurrent ACC and patients with non-ACC SGC. The primary endpoint was median progression-free survival (PFS); secondary endpoints were overall response rate (ORR), overall survival (OS), and toxicity.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Patient enrollment was prematurely terminated due to funding constraints. In total, 19 patients with ACC and 5 patients with non-ACC SGC were enrolled. The patients with ACC had a median OS of 30.0 months (95% CI 15.3-NR months), a median PFS of 8.3 months (95% CI 5.5–30.0 months), and a disease control rate (DCR) of 53% (10/19). 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引用次数: 0
摘要
nivolumab和ipilimumab的双重检查点抑制剂治疗已被FDA批准用于许多癌症部位。然而，其在ACC和非ACC唾液腺癌（non-ACC SGC）治疗中的作用尚未得到很好的证实。我们进行了Simon的nivolumab与ipilimumab的两阶段前瞻性单机构II期临床试验。分析了两个队列：转移性/复发性ACC患者和非ACC SGC患者。主要终点是中位无进展生存期（PFS）；次要终点是总缓解率（ORR）、总生存期（OS）和毒性。结果由于资金限制，患者入组被提前终止。共纳入19例ACC患者和5例非ACC SGC患者。ACC患者的中位OS为30.0个月（95% CI 15.3-NR个月），中位PFS为8.3个月（95% CI 5.5-30.0个月），疾病控制率（DCR）为53%（10/19）。ACC组的ORR为5% (CR为0%，n = 0；确诊PR为5%，n = 1)，其中1例患者在试验结束时病情持续稳定。非acc SGC患者的中位OS为10.4个月（95% CI为6.21- nr月），中位PFS为6.21个月（95% CI为2.83-NR月），DCR为40%（2/5）。该队列的ORR为0%。结论在复发或转移性ACC和非ACC SGC患者中，纳沃单抗联合伊匹单抗可实现中度疾病控制。需要进一步的研究来证实我们的发现。试验号：NCT03146650。
Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma (ACC) of all Anatomic Sites of Origin and Other Malignant Salivary Gland Tumors
Objective
Dual checkpoint inhibitor therapy with nivolumab and ipilimumab has been FDA approved for a number of cancer sites. However, its role in the treatment of ACC and non-ACC salivary gland carcinomas (non-ACC SGC) is not well established.
Methods and Analysis
We performed Simon's two-stage prospective single-institution Phase II clinical trial of nivolumab with ipilimumab. Two cohorts were analyzed: patients with metastatic/recurrent ACC and patients with non-ACC SGC. The primary endpoint was median progression-free survival (PFS); secondary endpoints were overall response rate (ORR), overall survival (OS), and toxicity.
Results
Patient enrollment was prematurely terminated due to funding constraints. In total, 19 patients with ACC and 5 patients with non-ACC SGC were enrolled. The patients with ACC had a median OS of 30.0 months (95% CI 15.3-NR months), a median PFS of 8.3 months (95% CI 5.5–30.0 months), and a disease control rate (DCR) of 53% (10/19). The ORR in the ACC group was 5% (CR 0%, n = 0; confirmed PR 5%, n = 1), with one patient having continued stable disease at the time of trial conclusion. The patients with non-ACC SGC had a median OS of 10.4 months (95% CI 6.21-NR months), a median PFS of 6.21 months (95% CI 2.83-NR months), and a DCR of 40% (2/5). The ORR in this cohort was 0%.
Conclusion
In patients with recurrent or metastatic ACC and non-ACC SGC, the combination of nivolumab with ipilimumab resulted in moderate disease control. Further studies are warranted to validate our findings.
期刊介绍：
Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas:
Clinical Cancer Research
Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations
Cancer Biology:
Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery.
Cancer Prevention:
Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach.
Bioinformatics:
Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers.
Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.
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