{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T01:06:22Z","timestamp":1780967182839,"version":"3.54.1"},"reference-count":19,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,7,20]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>Continued improvement in outcomes is needed for advanced cutaneous squamous cell carcinoma (cSCC).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>\n              Alliance A091802 is a randomized phase II trial of avelumab (800 mg IV once every 2 weeks) plus cetuximab (500 mg\/m\n              <jats:sup>2<\/jats:sup>\n              IV once every 2 weeks) versus avelumab alone once every 2 weeks for up to 2 years. Cetuximab was given for 1 year in the avelumab + cetuximab arm. Crossover at progression to avelumab + cetuximab was allowed. Randomization was 1:1, stratified by PD-L1 and HIV status. Patients had distant metastatic or unresectable locally advanced cSCC, were anti\u2013PD-1\/PD-L1 monoclonal antibody\u2013naive, had no previous cetuximab in the advanced setting, had an Eastern Cooperative Oncology Group performance status of 0-2, and could be HIV+ (CD4 &gt;200, viral load &lt;200). Patients with chronic lymphocytic leukemia, immunosuppression, or active autoimmune diseases were excluded. The primary end point was progression-free survival (PFS; null hypothesis: median = 12 months\n              <jats:italic toggle=\"yes\">v<\/jats:italic>\n              alternative hypothesis: 21 months or a 75% improvement, power of 80% with one-sided alpha .2, n = 57, 37 PFS events required). Secondary end points were overall survival, objective response rates (ORRs), clinical benefit rate, and toxicity.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              Sixty patients were enrolled; 57 patients were evaluable. The median age was 72 years, all were HIV\u2013; 75.4% was PD-L1+, 84.2% had head\/neck origin, 47.4% had distant metastasis, and there were no differences in baseline characteristics by arm. Avelumab + cetuximab significantly improved PFS versus avelumab (median, 11.1 [7.6-not reached (NR)]\n              <jats:italic toggle=\"yes\">v<\/jats:italic>\n              3.0 months [2.7-13.6] hazard ratio, 0.48 [95% CI, 0.23 to 0.97],\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              = .018). Avelumab patients who crossed over (n = 9) to combination had a median PFS after crossover of 11.3 months (5.8-NR). The confirmed ORR was 27.6% with avelumab + cetuximab and 21.4% with avelumab. Grade 3 treatment-related adverse events occurred in 48.3% and 21.5% of patients with avelumab + cetuximab (most common: rash [20.7%], infusion reaction [20.7%]) and avelumab, respectively.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>Avelumab + cetuximab significantly improved PFS versus avelumab alone in patients with advanced cSCC. Alliance A091802 supports a larger confirmatory study with the combination of cetuximab and PD-1:PD-(L)1 blockade.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/jco-25-00759","type":"journal-article","created":{"date-parts":[[2025,5,31]],"date-time":"2025-05-31T08:00:26Z","timestamp":1748678426000},"page":"2398-2408","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":12,"title":["Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct03944941","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1002-8301","authenticated-orcid":true,"given":"Dan P.","family":"Zandberg","sequence":"first","affiliation":[{"name":"UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob B.","family":"Allred","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5908-0939","authenticated-orcid":true,"given":"Ari J.","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"Kaczmar","sequence":"additional","affiliation":[{"name":"MUSC Hollings Cancer Center, Charleston, SC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2286-3555","authenticated-orcid":true,"given":"Paul","family":"Swiecicki","sequence":"additional","affiliation":[{"name":"University of Michigan Rogel Cancer Center, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricklie A.","family":"Julian","sequence":"additional","affiliation":[{"name":"University of Arizona Cancer Center, Tucson, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4015-5037","authenticated-orcid":true,"given":"Andrew S.","family":"Poklepovic","sequence":"additional","affiliation":[{"name":"Virginia Commonwealth University Health System, Richmond, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8691-0387","authenticated-orcid":true,"given":"Jessica R.","family":"Bauman","sequence":"additional","affiliation":[{"name":"Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minh D.","family":"Phan","sequence":"additional","affiliation":[{"name":"Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4972-1477","authenticated-orcid":true,"given":"Nabil F.","family":"Saba","sequence":"additional","affiliation":[{"name":"Emory University\/Winship Cancer Institute, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edgardo","family":"Rivera","sequence":"additional","affiliation":[{"name":"Nevada Cancer Specialists, Las Vegas, NV"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kendrith","family":"Rowland","sequence":"additional","affiliation":[{"name":"Carle Cancer Center, Urbana, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7846-8055","authenticated-orcid":true,"given":"Diwakar","family":"Davar","sequence":"additional","affiliation":[{"name":"UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Cordes","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6885-3742","authenticated-orcid":true,"given":"Alan L.","family":"Ho","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miao","family":"Zhang","sequence":"additional","affiliation":[{"name":"MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6193-5350","authenticated-orcid":true,"given":"Stephanie A.","family":"Berg","sequence":"additional","affiliation":[{"name":"Dana-Farber\/Partners CancerCare, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela N.","family":"Munster","sequence":"additional","affiliation":[{"name":"UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1813-5061","authenticated-orcid":true,"given":"Gary K.","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Case Western Reserve University, Cleveland, 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