{"doi":"10.1002/onco.13777","title":"Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)","abstract":"<jats:title>Abstract</jats:title>\n               <jats:sec>\n                  <jats:title>Lessons Learned</jats:title>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Background</jats:title>\n                  <jats:p>Endoglin is an angiogenic receptor expressed on proliferating tumor vessels and renal cell carcinoma (RCC) stem cells that is implicated as a mechanism of resistance to vascular endothelial growth factor receptor (VEGFR) inhibitors. This study evaluated an antiendoglin monoclonal antibody (carotuximab, TRC105) combined with axitinib in patients with advanced or metastatic clear cell renal cell carcinoma (mccRCC) who had progressed following one or more prior VEGF inhibitors.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Methods</jats:title>\n                  <jats:p>TRAXAR was a multicenter, international randomized 1:1 (stratified by ECOG, 0 vs. 1), phase II study of carotuximab combined with axitinib versus axitinib alone in mccRCC patients who had progressed following one or more prior VEGF inhibitors. The primary endpoint was progression-free survival (PFS) assessed by independent central review (ICR) per RECIST 1.1</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Results</jats:title>\n                  <jats:p>A total of 150 patients were randomized. The combination therapy resulted in shorter median PFS by RECIST 1.1 than axitinib monotherapy (6.7 vs. 11.4 months). The combination was tolerated similarly to axitinib monotherapy, and there were no treatment related deaths. Exploratory evaluation of pretreatment circulating biomarkers suggested the combination might benefit patients who have low baseline VEGF levels.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion</jats:title>\n                  <jats:p>The combination of carotuximab with axitinib did not demonstrate additional efficacy over single agent axitinib in patients with mccRCC who progressed following one or more prior VEGF inhibitor treatment.</jats:p>\n               </jats:sec>","journal":"The Oncologist","year":2021,"id":636691,"datarank":0.3596842909197557,"base_score":2.3978952727983707,"endowment":2.3978952727983707,"self_citation_contribution":0.3596842909197557,"citation_network_contribution":0.0,"self_endowment_contribution":0.3596842909197557,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":10,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":289544,"name":"Yousef Zakharia","orcid":"0000-0001-9480-2626","position":1,"is_corresponding":false},{"id":1652688,"name":"Sumanta Pal","orcid":null,"position":2,"is_corresponding":false},{"id":240464,"name":"Judit Kocsis","orcid":"0000-0002-6110-9750","position":3,"is_corresponding":false},{"id":1547569,"name":"Russell Pachynski","orcid":null,"position":4,"is_corresponding":false},{"id":1652697,"name":"Alexandr Poprach","orcid":null,"position":5,"is_corresponding":false},{"id":239530,"name":"Andrew B. Nixon","orcid":"0000-0003-3971-2964","position":6,"is_corresponding":false},{"id":242497,"name":"Yingmiao Liu","orcid":"0000-0003-3516-5844","position":7,"is_corresponding":false},{"id":1652705,"name":"Mark Starr","orcid":null,"position":8,"is_corresponding":false},{"id":784815,"name":"Jing Lyu","orcid":"0000-0001-8886-3289","position":9,"is_corresponding":false},{"id":346841,"name":"Kouros Owzar","orcid":"0000-0002-3340-1287","position":10,"is_corresponding":false},{"id":1652708,"name":"Mollie deShazo","orcid":null,"position":11,"is_corresponding":false},{"id":565404,"name":"Primo Lara","orcid":null,"position":12,"is_corresponding":false},{"id":1527317,"name":"Lajos Geczi","orcid":null,"position":13,"is_corresponding":false},{"id":70210,"name":"Thai H. Ho","orcid":"0000-0003-0023-2939","position":14,"is_corresponding":false},{"id":1652709,"name":"Meghara Walsh","orcid":null,"position":15,"is_corresponding":false},{"id":1652710,"name":"Bonne Adams","orcid":null,"position":16,"is_corresponding":false},{"id":1652711,"name":"Liz Robertson","orcid":null,"position":17,"is_corresponding":false},{"id":1652712,"name":"Mohamed Darif","orcid":null,"position":18,"is_corresponding":false},{"id":1652713,"name":"Charles Theuer","orcid":null,"position":19,"is_corresponding":false},{"id":642439,"name":"Neeraj Agarwal","orcid":"0000-0002-1025-4114","position":20,"is_corresponding":false},{"id":16405,"name":"Toni K. Choueiri","orcid":"0000-0002-9201-3217","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Clinical Results and Biomarker Analyses of Axitinib and TRC105 versus Axitinib Alone in Patients with Advanced or Metastatic Renal Cell Carcinoma (TRAXAR)","abstract":"<jats:title>Abstract</jats:title>\n               <jats:sec>\n                  <jats:title>Lessons Learned</jats:title>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Background</jats:title>\n                  <jats:p>Endoglin is an angiogenic receptor expressed on proliferating tumor vessels and renal cell carcinoma (RCC) stem cells that is implicated as a mechanism of resistance to vascular endothelial growth factor receptor (VEGFR) inhibitors. This study evaluated an antiendoglin monoclonal antibody (carotuximab, TRC105) combined with axitinib in patients with advanced or metastatic clear cell renal cell carcinoma (mccRCC) who had progressed following one or more prior VEGF inhibitors.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Methods</jats:title>\n                  <jats:p>TRAXAR was a multicenter, international randomized 1:1 (stratified by ECOG, 0 vs. 1), phase II study of carotuximab combined with axitinib versus axitinib alone in mccRCC patients who had progressed following one or more prior VEGF inhibitors. The primary endpoint was progression-free survival (PFS) assessed by independent central review (ICR) per RECIST 1.1</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Results</jats:title>\n                  <jats:p>A total of 150 patients were randomized. The combination therapy resulted in shorter median PFS by RECIST 1.1 than axitinib monotherapy (6.7 vs. 11.4 months). The combination was tolerated similarly to axitinib monotherapy, and there were no treatment related deaths. Exploratory evaluation of pretreatment circulating biomarkers suggested the combination might benefit patients who have low baseline VEGF levels.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion</jats:title>\n                  <jats:p>The combination of carotuximab with axitinib did not demonstrate additional efficacy over single agent axitinib in patients with mccRCC who progressed following one or more prior VEGF inhibitor treatment.</jats:p>\n               </jats:sec>","is_dataset_classified":null,"base_score":2.3978952727983707,"endowment":2.3978952727983707,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"33829609","pmcid":"PMC8265348","openalex_id":"https://openalex.org/W3142337831","authors":[],"funders":[{"funder_name":"NCI NIH HHS","grant_id":"P30 CA093373","title":null}],"total_grants":1,"fwci":1.0429,"citation_percentile":0.76621641,"influential_citations":0,"citation_trend":[{"year":2021,"count":1},{"year":2022,"count":4},{"year":2023,"count":1},{"year":2024,"count":2},{"year":2025,"count":1},{"year":2026,"count":1}],"oa_status":"bronze","license":"https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model","oa_locations":[{"url":"https://academic.oup.com/oncolo/article-pdf/26/7/560/42367333/oncolo_26_7_560.pdf","host_type":"journal"},{"url":"https://academic.oup.com/oncolo/article-pdf/26/7/560/42367333/oncolo_26_7_560.pdf","host_type":"publisher"},{"url":"https://onlinelibrary.wiley.com/doi/pdf/10.1002/onco.13777","host_type":"publisher"},{"url":"https://onlinelibrary.wiley.com/doi/full-xml/10.1002/onco.13777","host_type":"publisher"},{"url":"https://doi.org/10.1002/onco.13777","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/33829609","host_type":"repository"},{"url":"https://escholarship.org/uc/item/6xc9d29b","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/8265348","host_type":"repository"}],"fields_of_study":["Renal cell carcinoma treatment","Angiogenesis and VEGF in Cancer","Bladder and Urothelial Cancer Treatments"],"mesh_terms":["Axitinib","Antibodies, Monoclonal","Carcinoma, Renal Cell","Humans","Kidney Neoplasms","Vascular Endothelial Growth Factor A"],"keywords":["Axitinib","Medicine","Renal cell carcinoma","Sorafenib","Oncology","Internal medicine","Clinical endpoint","Vascular endothelial growth factor","Urology","Clinical trial","Sunitinib","Hepatocellular carcinoma","VEGF receptors","Renal cell cancer","Phase Ii","Endoglin","Trc105","Carotuximab","Traxar"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[{"name":"nct"}],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-06T17:32:30.946661Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}