NCI9673: A multi-institutional eETCTN phase II study of nivolumab in refractory metastatic squamous cell carcinoma of the anal canal (SCCA).
Year: 2016
Type: conference-abstract
Abstract: 3503 Background: The incidence of SCCA continues to rise annually in the US. 20% of patients (pts) will develop metastatic (met) disease which lacks a consensus approach to treatment. SCCA is largely driven by immune evasion of HPV-specific CD8 and CD4 T cells which promote oncogenesis for SCCA. Nivolumab (Nivo), a monoclonal antibody targeting PD-1 on T cells, promotes immune-mediated anti-tumor activity of T cells against HPV-positive cells in vitro. This is the first phase II trial of Nivo for pts with refractory met SCCA. Methods: Previously treated but immunotherapy naïve met SCCA pts were eligible. PD-L1 expression was not required. HIV+ (CD4 count > 300/uL) and hepatitis B/C pts were eligible. A Simon two-stage phase II trial (Ho: p < .05, Ha: p ≥ .20) was conducted. All pts were evaluated by RECIST Criteria 1.1. Pts received Nivo (3 mg/kg) IV every 2 weeks. Optional pre-treatment and on-treatment tissue biopsies and plasma samples were collected for immune biomarkers and HPV/p16 status. All correlatives were evaluated at MDACC by the Immunotherapy Platform team and the Core Facility. Results: 39 pts were screened across the ETCTN network (May 2015 - October 2015); 37 pts were eligible. Median age was 56 years (interquartile range [IQR], 51.1-63.6); M:F was 12:25. Median number of prior therapies: 2 (range 1-8). All pts were evaluable for toxicity; 33 pts were evaluable for response. Median number of cycles: 6 (IQR, 3-10). Seven (21%) pts had a partial response and 19 (58%) pts had stable disease; disease control rate of 79%. Ten pts (one HIV+) remain on study [7 pts for > 6 months (M)]. Median progression-free survival was 4.1M. Common adverse events (AE): fatigue, nausea, and rash. Six pts had grade 3 AE’s: fatigue (N = 2) and one pt each of pneumonitis, rash, anemia, and hyperglycemia. Conclusions: Currently, there is no consensus approach for met SCCA. NCI9673 is the first prospective phase II trial of nivolumab in refractory metastatic SCCA. Single agent nivolumab demonstrated potentially meaningful activity and was well tolerated. Further evaluation of immune checkpoint therapy in met SCCA is justified. Updated clinical results will be presented. Exploratory correlative work is ongoing. Clinical trial information: NCT02314169.
Source: Journal of Clinical Oncology
Authors: Van Karlyle Morris, Kristen Keon Ciombor, Mohamed E. Salem, Halla Sayed Nimeiri, Syma Iqbal, Preet Paul Singh, Blase N. Polite, Dustin A. Deming, Emily Chan, James Lloyd Wade, Tanios S. Bekaii-Saab, Hope Elizabeth Uronis, Manolo G Pasia, Gail Bland, Robert A. Wolff, Aki Ohinata, Chimela Ohaji, Jane Rogers, Padmanee Sharma, Cathy Eng
Institutions: The University of Texas MD Anderson Cancer Center, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Georgetown University, Georgetown Lombardi Comprehensive Cancer Center, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, USC Norris Comprehensive Cancer Center, Mayo Clinic, University of Chicago, University of Wisconsin–Madison, UW Health University Hospital, Vanderbilt University Medical Center, Duke Medical Center
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W2890585021