Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma

We report the basal cell cancer (BCC) cohort of the SWOG/NCI 1609 Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors (DART), a phase II prospective, multicenter basket trial of nivolumab and ipilimumab. The primary endpoint was objective response rate (ORR) (RECIST v1.1). Overall survival (OS)...

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Published in:NPJ precision oncology Vol. 9; no. 1; pp. 24 - 7
Main Authors: Patel, Sandip P., Cano-Linson, Eleanor, Chae, Young Kwang, Schokrpur, Shiruyeh, Lao, Christopher D., Powers, Benjamin C., Victor, Adrienne I., Onitilo, Adedayo A., Shin, Sarah, Takebe, Naoko, Threlkel, Sara, McLeod, Christine M., Chen, Helen X., Sharon, Elad, Othus, Megan, Ryan, Christopher W., Blanke, Charles D., Kurzrock, Razelle
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 24.01.2025
Nature Publishing Group
Nature Portfolio
Subjects:
692/308/409
692/4028/67/1813/1349
Cancer Research
Diarrhea
Gene Therapy
Human Genetics
Immunotherapy
Internal Medicine
Lung cancer
Medical research
Medicine
Medicine & Public Health
Metastasis
Monoclonal antibodies
Oncology
Patients
Skin cancer
Targeted cancer therapy
Toxicity
Tumors
ISSN:2397-768X, 2397-768X
Online Access:Get full text
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Summary:We report the basal cell cancer (BCC) cohort of the SWOG/NCI 1609 Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors (DART), a phase II prospective, multicenter basket trial of nivolumab and ipilimumab. The primary endpoint was objective response rate (ORR) (RECIST v1.1). Overall survival (OS), progression-free survival (PFS), and toxicity were secondary endpoints. Sixteen patients with advanced/metastatic BCC were evaluable. The ORR was 31% (95% CI, 19–50%), and the 12-month OS, 75% (95% CI, 57–100%). Median PFS was 9.3 months (95% CI, 3.3–NA). Of 15 patients evaluable for clinical benefit, five partial responses (PRs) and five stable disease >6 months (total = 10/15 (66.7%)) were seen. The most common toxicities included fatigue (37.5%), pruritis (31.3%), and diarrhea (25%). In patients with advanced/metastatic BCC, ipilimumab and nivolumab produced an ORR of 31% and prolonged (>6 months) PFS in 73% of patients, with seven PFS/iPFS of >1 year, including one with prior anti-PD-1. ClinicalTrials.gov ID: NCT02834013 (Registered 7/15/2016; https://clinicaltrials.gov/ct2/show/NCT02834013 ).
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ISSN:2397-768X
2397-768X
DOI:10.1038/s41698-024-00798-1