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 ).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1038/s41698-024-00798-1 | DOI Listing |
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759674 | PMC |
Publication Analysis
Top Keywords
Similar Publications
Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma.
NPJ Precis Oncol
January 2025
University of California at San Diego Moores Cancer Center, La Jolla, CA, USA.
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).
View Article and Find Full Text PDFExploring novel immunotherapy in advanced esophageal squamous cell carcinoma: Is targeting TIGIT an answer?
Esophagus
January 2025
Department of Medical Oncology, National Taiwan University Cancer Center, 7 Chung-Shan South Road, Taipei, 10002, Taiwan.
Esophageal squamous cell carcinoma (ESCC) is a prevalent and highly lethal malignancy in Asia. Recent advancements in immune checkpoint inhibitors (ICIs) have markedly transformed the systemic therapy landscape for ESCC. Anti-PD-1-based combination with chemotherapy or with ipilimumab, an anti-CTLA-4 antibody, have been established as the new standard first-line treatments for patients with advanced ESCC.
View Article and Find Full Text PDFFractionated low-dose radiotherapy primes the tumor microenvironment for immunotherapy in a murine mesothelioma model.
Cancer Immunol Immunother
January 2025
National Centre for Asbestos Related Diseases, The University of Western Australia, Perth, Australia.
Combination immune checkpoint inhibitors (nivolumab and ipilimumab) are currently a first-line treatment for mesothelioma; however, not all patients respond. The efficacy of treatment is influenced by the tumor microenvironment. Murine mesothelioma tumors were irritated with various radiotherapy doses.
View Article and Find Full Text PDFPhase II trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors SWOG/NCI experience: invasive mucinous or non-mucinous lepidic adenocarcinoma of the lung (formerly bronchioloalveolar carcinoma).
Ther Adv Med Oncol
November 2024
Medical College of Wisconsin, MCW Cancer Center/Administrative Office, 9200 West Wisconsin Avenue, Suite C5300, Milwaukee, WI 53226, USA.
Background: Anti-programmed death-1 (PD-1)/cytotoxic T lymphocyte antigen-4 antibodies are efficacious in various malignancies.
Objectives: This study presents the first results of ipilimumab-nivolumab in invasive mucinous or non-mucinous lepidic adenocarcinoma (invasive mucinous adenocarcinoma (IMA) or invasive non-mucinous lepidic adenocarcinomas (INLA), respectively) of the lung.
Design: Dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) is a prospective, open-label, multicenter (1016 US sites), multi-cohort phase II trial of ipilimumab (1 mg/kg intravenously (IV) every 6 weeks) plus nivolumab (240 mg IV every 2 weeks).
A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors SWOG S1609: Vulvar Cancers.
Clin Cancer Res
January 2025
Medical College of Wisconsin, Milwaukee, Wisconsin.
Article Synopsis
- The SWOG S1609 DART trial investigated the effectiveness of dual therapy with ipilimumab and nivolumab in patients with vulvar cancers, showing initial promising results.
- In this phase II clinical trial involving 16 patients, the objective response rate was 18.8%, with some patients exhibiting durable responses and stable disease.
- Adverse effects were common, including diarrhea and fatigue, with 25% of patients experiencing severe side effects, highlighting the need for ongoing studies to identify response and resistance markers.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!