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Clin. Cancer Res., Nov 19 2024, | https://doi.org/10.1158/1078-0432.CCR-24-1957
A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: Vulvar Cancers
Young Kwang Chae 1, Lucy Corthell 2, Sandip Pravin Patel 3, Robert Edwards 4, Jennifer M Scalici 5, Hye Sung Kim 6, Liam Il-Young Chung 1, Megan Othus 7, Christine M McLeod 8, Helen X Chen 9, Elad Sharon 9, Howard Streicher 10, Christopher W Ryan 11, Charles D Blanke 11, Razelle Kurzrock 12
1Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
2Fred Hutchinson Cancer Center, United States.
3UC San Diego Health System, La Jolla, United States.
4University of Pittsburgh, Pittsburgh, United States.
5Winship Cancer Institute, Atlanta, GA, United States.
6Temple University Hospital, Philadelphia, PA, United States.
7Fred Hutchinson Cancer Center, Seattle, WA, United States.
8SWOG Data Operations Center, United States.
9National Cancer Institute, Bethesda, MD, United States.
10National Cancer Institute, Rockville, MD, United States.
11Oregon Health & Science University, Portland, OR, United States.
12Worldwide Innovative Network (WIN) for Personalized Cancer Therapy, Villejuif, France.
Corresponding Author : Young Kwang Chae
1Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
2Fred Hutchinson Cancer Center, United States.
3UC San Diego Health System, La Jolla, United States.
4University of Pittsburgh, Pittsburgh, United States.
5Winship Cancer Institute, Atlanta, GA, United States.
6Temple University Hospital, Philadelphia, PA, United States.
7Fred Hutchinson Cancer Center, Seattle, WA, United States.
8SWOG Data Operations Center, United States.
9National Cancer Institute, Bethesda, MD, United States.
10National Cancer Institute, Rockville, MD, United States.
11Oregon Health & Science University, Portland, OR, United States.
12Worldwide Innovative Network (WIN) for Personalized Cancer Therapy, Villejuif, France.
Corresponding Author : Young Kwang Chae
Abstract
Background: Dual PD-1/CTLA-4 inhibition shows promise in various malignancies. The SWOG S1609 DART trial presents initial results of ipilimumab/nivolumab in vulvar cancers.
Methods: DART is a prospective/open-label/multicenter (1,016 US sites)/multi-cohort phase II clinical trial of ipilimumab (1mg/kg intravenously every 6 weeks) plus nivolumab (240mg intravenously every 2 weeks). The primary endpoint was objective response rate [ORR, confirmed complete and partial responses (CR and PR, respectively)] per RECISTv1.1; progression-free survival (PFS), overall survival (OS), clinical benefit rate [CBR; overall response plus stable disease (SD) ≥6 months], and toxicity are secondary endpoints.
Results: Sixteen evaluable patients (median age, 55.5 years; 0-6 prior therapies; no prior immunotherapy) were analyzed, all of whom had squamous cell carcinoma histology. ORR was 18.8% (3/16), CBR was 25% (4/16), and CBR plus unconfirmed PR rate was 31% (5/16); PFS was 34.1, 16.7. 15.5, 7.2 and 7.0 months for these five patients. The median PFS and OS were 2.2 and 7.6 months. The most common adverse events were diarrhea, fatigue, pruritus, anorexia, and nausea (25%, n=4 each). Grade 3-4 adverse events occurred in 25% of patients (n=4). There was 1 grade 1-2 adverse event (6.7%) that led to discontinuation, and 1 (6.7%) grade 5 death adverse event.
Conclusion: Ipilimumab plus nivolumab in vulvar cancers resulted in an objective response in three out of 16 patients, all of whom had durable responses lasting over one year. Notably, two additional patients experienced durable SD and unconfirmed PR. Correlative studies to determine response and resistance markers are ongoing.
Methods: DART is a prospective/open-label/multicenter (1,016 US sites)/multi-cohort phase II clinical trial of ipilimumab (1mg/kg intravenously every 6 weeks) plus nivolumab (240mg intravenously every 2 weeks). The primary endpoint was objective response rate [ORR, confirmed complete and partial responses (CR and PR, respectively)] per RECISTv1.1; progression-free survival (PFS), overall survival (OS), clinical benefit rate [CBR; overall response plus stable disease (SD) ≥6 months], and toxicity are secondary endpoints.
Results: Sixteen evaluable patients (median age, 55.5 years; 0-6 prior therapies; no prior immunotherapy) were analyzed, all of whom had squamous cell carcinoma histology. ORR was 18.8% (3/16), CBR was 25% (4/16), and CBR plus unconfirmed PR rate was 31% (5/16); PFS was 34.1, 16.7. 15.5, 7.2 and 7.0 months for these five patients. The median PFS and OS were 2.2 and 7.6 months. The most common adverse events were diarrhea, fatigue, pruritus, anorexia, and nausea (25%, n=4 each). Grade 3-4 adverse events occurred in 25% of patients (n=4). There was 1 grade 1-2 adverse event (6.7%) that led to discontinuation, and 1 (6.7%) grade 5 death adverse event.
Conclusion: Ipilimumab plus nivolumab in vulvar cancers resulted in an objective response in three out of 16 patients, all of whom had durable responses lasting over one year. Notably, two additional patients experienced durable SD and unconfirmed PR. Correlative studies to determine response and resistance markers are ongoing.
논문정보
- Research article
- 2024년 11월 (BRIC 등록일 2024-11-20)
- 국외 연구진
- 의약학 > 종양의학
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