Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma
Abstract 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 surv...
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| Language: | English |
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Nature Portfolio
2025-01-01
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| Series: | npj Precision Oncology |
| Online Access: | https://doi.org/10.1038/s41698-024-00798-1 |
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| author | Sandip P. Patel Eleanor Cano-Linson Young Kwang Chae Shiruyeh Schokrpur Christopher D. Lao Benjamin C. Powers Adrienne I. Victor Adedayo A. Onitilo Sarah Shin Naoko Takebe Sara Threlkel Christine M. McLeod Helen X. Chen Elad Sharon Megan Othus Christopher W. Ryan Charles D. Blanke Razelle Kurzrock |
| author_facet | Sandip P. Patel Eleanor Cano-Linson Young Kwang Chae Shiruyeh Schokrpur Christopher D. Lao Benjamin C. Powers Adrienne I. Victor Adedayo A. Onitilo Sarah Shin Naoko Takebe Sara Threlkel Christine M. McLeod Helen X. Chen Elad Sharon Megan Othus Christopher W. Ryan Charles D. Blanke Razelle Kurzrock |
| author_sort | Sandip P. Patel |
| collection | DOAJ |
| description | Abstract 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 ). |
| format | Article |
| id | doaj-art-f1c3240c276948d7b13013f8f41b2d75 |
| institution | Kabale University |
| issn | 2397-768X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Precision Oncology |
| spelling | doaj-art-f1c3240c276948d7b13013f8f41b2d752025-01-26T12:12:55ZengNature Portfolionpj Precision Oncology2397-768X2025-01-01911710.1038/s41698-024-00798-1Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinomaSandip P. Patel0Eleanor Cano-Linson1Young Kwang Chae2Shiruyeh Schokrpur3Christopher D. Lao4Benjamin C. Powers5Adrienne I. Victor6Adedayo A. Onitilo7Sarah Shin8Naoko Takebe9Sara Threlkel10Christine M. McLeod11Helen X. Chen12Elad Sharon13Megan Othus14Christopher W. Ryan15Charles D. Blanke16Razelle Kurzrock17University of California at San Diego Moores Cancer CenterSWOG Statistical CenterNorthwestern UniversityUniversity of California at San Diego Moores Cancer CenterUniversity of MichiganUniversity of Kansas Cancer CenterUniversity of RochesterMarshfield Medical Center—WestonNational Cancer Institute, Developmental Therapeutics ClinicNational Cancer Institute, Developmental Therapeutics ClinicSWOG Statistical CenterSWOG Data Operations Center/ Cancer Research And BiostatisticsNational Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation ProgramDana-Farber/Harvard Cancer CenterSWOG Statistical CenterOregon Health & Science UniversitySWOG Group Chair’s Office, Oregon Health & Science University, Knight Cancer InstituteUniversity of California at San Diego Moores Cancer CenterAbstract 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 ).https://doi.org/10.1038/s41698-024-00798-1 |
| spellingShingle | Sandip P. Patel Eleanor Cano-Linson Young Kwang Chae Shiruyeh Schokrpur Christopher D. Lao Benjamin C. Powers Adrienne I. Victor Adedayo A. Onitilo Sarah Shin Naoko Takebe Sara Threlkel Christine M. McLeod Helen X. Chen Elad Sharon Megan Othus Christopher W. Ryan Charles D. Blanke Razelle Kurzrock Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma npj Precision Oncology |
| title | Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma |
| title_full | Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma |
| title_fullStr | Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma |
| title_full_unstemmed | Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma |
| title_short | Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma |
| title_sort | dual anti ctla 4 and anti pd 1 blockade in metastatic basal cell carcinoma |
| url | https://doi.org/10.1038/s41698-024-00798-1 |
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