{"doi":"10.1002/ijc.34267","title":"Phase 1 trial of <scp>CV301</scp> in combination with <scp>anti‐PD</scp>‐1 therapy in <scp>nonsquamous non‐small</scp> cell lung cancer","abstract":"CV301, a poxviral-based vaccine, has been evaluated in a phase 1 clinical trial (NCT02840994) and shown to be safe and immunologically active (phase 1a). Preclinical data support a combination of CV301 with programmed death-1 inhibitors, which has been evaluated in the phase 1b part of this trial and is reported here. Patients with advanced nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations received two priming doses of modified vaccinia Ankara-BN-CV301 (MVA) 4 weeks apart, followed by boosting doses of fowlpox-CV301 (FPV) at increasing time intervals for a maximum of 17 doses in combination with nivolumab for cohort 1 (C1) and 15 doses in combination with pembrolizumab for cohort 2 (C2). The primary objective was evaluation of safety and tolerability. Between October 2017 and September 14, 2018, patients were enrolled (C1: 4; median age: 64 years). Mean treatment duration was 332 days in C1 and 289 days in C2. CTCAE ≥grade 3 adverse events (AEs) were observed in four (100%) patients in C1 and three (37.5%) patients in C2. There was one death on trial. Immune-related AEs (irAEs) fulfilling criteria for a dose-limiting toxicity included 1 case of pneumonitis. Among 11 evaluable patients, 1 (9%) had a complete response, 1 (9%) had a partial response and 9 (82%) had stable disease. We conclude that CV301 administered with PD-1 inhibitors is safe and clinically active in patients with advanced NSCLC. The frequency or severity of AEs is not increased, including irAEs for each component of the combination.","journal":"International Journal of Cancer","year":2022,"id":265283,"datarank":0.5641203200601133,"base_score":2.4849066497880004,"endowment":2.4849066497880004,"self_citation_contribution":0.37273599746820013,"citation_network_contribution":0.19138432259191307,"self_endowment_contribution":0.37273599746820013,"citer_contribution":0.19138432259191307,"corpus_percentile":null,"corpus_rank":null,"citation_count":11,"citer_count":10,"citers_with_citation_signal":9,"citers_with_endowment":9,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9554,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02840994"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":33772,"name":"Jhanelle E. Gray","orcid":"0000-0003-1304-7062","position":1,"is_corresponding":false},{"id":518148,"name":"Siddhartha Devarakonda","orcid":"0000-0003-2693-3848","position":2,"is_corresponding":false},{"id":923896,"name":"Ruemu Birhiray","orcid":"0000-0003-0055-4313","position":3,"is_corresponding":false},{"id":531249,"name":"Borys Korchin","orcid":null,"position":4,"is_corresponding":false},{"id":924359,"name":"Erika Menius","orcid":null,"position":5,"is_corresponding":false},{"id":239940,"name":"Renee N. Donahue","orcid":"0000-0002-6828-3073","position":6,"is_corresponding":false},{"id":239943,"name":"Jeffrey Schlom","orcid":"0000-0001-7932-4072","position":7,"is_corresponding":false},{"id":239942,"name":"James L. Gulley","orcid":"0000-0002-6569-2912","position":8,"is_corresponding":false},{"id":250451,"name":"Arun Rajan","orcid":"0000-0003-2776-3385","position":0,"is_corresponding":true}],"reference_count":22,"raw_metadata":null,"created_at":"2026-07-19T00:26:45.905331Z","pmid":"36054490","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":[]}