dc.contributor.author | Vergote, I | |
dc.contributor.author | Van Nieuwenhuysen, E | |
dc.contributor.author | O'Cearbhaill, RE | |
dc.contributor.author | Westermann, A | |
dc.contributor.author | Lorusso, D | |
dc.contributor.author | Ghamande, S | |
dc.contributor.author | Collins, DC | |
dc.contributor.author | Banerjee, S | |
dc.contributor.author | Mathews, CA | |
dc.contributor.author | Gennigens, C | |
dc.contributor.author | Cibula, D | |
dc.contributor.author | Tewari, KS | |
dc.contributor.author | Madsen, K | |
dc.contributor.author | Köse, F | |
dc.contributor.author | Jackson, AL | |
dc.contributor.author | Boere, IA | |
dc.contributor.author | Scambia, G | |
dc.contributor.author | Randall, LM | |
dc.contributor.author | Sadozye, A | |
dc.contributor.author | Baurain, J-F | |
dc.contributor.author | Gort, E | |
dc.contributor.author | Zikán, M | |
dc.contributor.author | Denys, HG | |
dc.contributor.author | Ottevanger, N | |
dc.contributor.author | Forget, F | |
dc.contributor.author | Mondrup Andreassen, C | |
dc.contributor.author | Eaton, L | |
dc.contributor.author | Chisamore, MJ | |
dc.contributor.author | Viana Nicacio, L | |
dc.contributor.author | Soumaoro, I | |
dc.contributor.author | Monk, BJ | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2023-11-23T11:05:32Z | |
dc.date.available | 2023-11-23T11:05:32Z | |
dc.date.issued | 2023-12-20 | |
dc.identifier.citation | Journal of Clinical Oncology, 2023, pp. JCO2300720 - | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/6068 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.23.00720 | |
dc.identifier.doi | 10.1200/JCO.23.00720 | |
dc.description.abstract | PURPOSE: Tissue factor is highly expressed in cervical carcinoma and can be targeted by tisotumab vedotin (TV), an antibody-drug conjugate. This phase Ib/II study evaluated TV in combination with bevacizumab, pembrolizumab, or carboplatin for recurrent or metastatic cervical cancer (r/mCC). METHODS: This open-label, multicenter study (ClinicalTrials.gov identifier: NCT03786081) included dose-escalation arms that assessed dose-limiting toxicities (DLTs) and identified the recommended phase II dose (RP2D) of TV in combination with bevacizumab (arm A), pembrolizumab (arm B), or carboplatin (arm C). The dose-expansion arms evaluated TV antitumor activity and safety at RP2D in combination with carboplatin as first-line (1L) treatment (arm D) or with pembrolizumab as 1L (arm E) or second-/third-line (2L/3L) treatment (arm F). The primary end point of dose expansion was objective response rate (ORR). RESULTS: A total of 142 patients were enrolled. In dose escalation (n = 41), no DLTs were observed; the RP2D was TV 2 mg/kg plus bevacizumab 15 mg/kg on day 1 once every 3 weeks, pembrolizumab 200 mg on day 1 once every 3 weeks, or carboplatin AUC 5 on day 1 once every 3 weeks. In dose expansion (n = 101), the ORR was 54.5% (n/N, 18/33; 95% CI, 36.4 to 71.9) with 1L TV + carboplatin (arm D), 40.6% (n/N, 13/32; 95% CI, 23.7 to 59.4) with 1L TV + pembrolizumab (arm E), and 35.3% (12/34; 19.7 to 53.5) with 2L/3L TV + pembrolizumab (arm F). The median duration of response was 8.6 months, not reached, and 14.1 months, in arms D, E, and F, respectively. Grade ≥3 adverse events (≥15%) were anemia, diarrhea, nausea, and thrombocytopenia in arm D and anemia in arm F (none ≥15%, arm E). CONCLUSION: TV in combination with bevacizumab, carboplatin, or pembrolizumab demonstrated manageable safety and encouraging antitumor activity in treatment-naive and previously treated r/mCC. | |
dc.format | Print-Electronic | |
dc.format.extent | JCO2300720 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-07-12 | |
dc.date.updated | 2023-11-23T11:04:38Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1200/JCO.23.00720 | |
rioxxterms.licenseref.startdate | 2023-08-31 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37651655 | |
pubs.organisational-group | ICR | |
pubs.organisational-group | ICR/Primary Group | |
pubs.organisational-group | ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.23.00720 | |
dc.contributor.icrauthor | Banerjee, Susana | |
icr.provenance | Deposited by Mr Arek Surman on 2023-11-23. Deposit type is initial. No. of files: 1. Files: vergote-et-al-2023-tisotumab-vedotin-in-combination-with-carboplatin-pembrolizumab-or-bevacizumab-in-recurrent-or.pdf | |