{"doi":"10.1002/cncr.35126","title":"Randomized phase 2 trial of tremelimumab and durvalumab in combination versus sequentially in recurrent platinum‐resistant ovarian cancer","abstract":"BACKGROUND: Single-agent immune checkpoint inhibitors (ICIs) have demonstrated limited responses in recurrent ovarian cancer; however, 30%-40% of patients achieve stable disease. The primary objective was to estimate progression-free survival (PFS) after sequential versus combination cytotoxic T-lymphocyte antigen 4 and programmed death ligand 1 ICIs in patients with platinum-resistant high-grade serous ovarian cancer (HGSOC). METHODS: Patients were randomized to a sequential arm (tremelimumab followed by durvalumab on progression) or a combination arm (tremelimumab plus durvalumab, followed by durvalumab) via a Bayesian adaptive design that made it more likely for patients to be randomized to the more effective arm. The primary end point was immune-related PFS (irPFS). RESULTS: Sixty-one subjects were randomized to sequential (n = 38) or combination therapy (n = 23). Thirteen patients (34.2%) in the sequential arm received durvalumab. There was no difference in PFS in the sequential arm (1.84 months; 95% CI, 1.77-2.17 months) compared with the combination arm (1.87 months; 95% CI, 1.77-2.43 months) (p = .402). In the sequential arm, no responses were observed, although 12 patients (31.6%) demonstrated stable disease. In the combination arm, two patients (8.7%) had partial response, whereas one patient (4.4%) had stable disease. Adverse events were consistent with those previously reported for ICIs. Patient-reported outcomes were similar in both arms. CONCLUSIONS: There was no difference in irPFS for combination tremelimumab plus durvalumab compared to tremelimumab alone (administered as part of a sequential treatment strategy) in a heavily pretreated population of patients with platinum-resistant HGSOC. Response rates were comparable to prior reports, although the combination regimen did not add significant benefit, as has been previously described.","journal":"Cancer","year":2023,"id":337800,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":18,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9502,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":328713,"name":"Anne Knisely","orcid":"0000-0003-4200-2293","position":1,"is_corresponding":false},{"id":1069760,"name":"Naomi Adjei","orcid":"0000-0001-5071-3525","position":2,"is_corresponding":false},{"id":268549,"name":"Bryan Fellman","orcid":"0000-0002-1810-5762","position":3,"is_corresponding":false},{"id":268557,"name":"Ying Yuan","orcid":"0000-0003-3163-480X","position":4,"is_corresponding":false},{"id":659607,"name":"Ami Patel","orcid":"0000-0001-7875-9891","position":5,"is_corresponding":false},{"id":820656,"name":"Cai Xu","orcid":"0000-0002-1412-4229","position":6,"is_corresponding":false},{"id":233757,"name":"Shannon N. 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Gershenson","orcid":"0000-0001-9712-2140","position":12,"is_corresponding":false},{"id":661416,"name":"Raghu Vikram","orcid":"0000-0002-1067-7934","position":13,"is_corresponding":false},{"id":419866,"name":"Tharakeswara Bathala","orcid":"0000-0001-8342-4519","position":14,"is_corresponding":false},{"id":704324,"name":"David Vining","orcid":null,"position":15,"is_corresponding":false},{"id":1070257,"name":"Dhakshina Moorthy Ganeshan","orcid":null,"position":16,"is_corresponding":false},{"id":40782,"name":"Karen H. Lu","orcid":"0000-0002-5317-9927","position":17,"is_corresponding":false},{"id":268550,"name":"Charlotte C. Sun","orcid":"0000-0003-0850-7853","position":18,"is_corresponding":false},{"id":401895,"name":"Larissa A. Meyer","orcid":"0000-0002-2687-7463","position":19,"is_corresponding":false},{"id":256637,"name":"Amir A. 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