Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer

Summary

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.

Timeline

Start

2019-02-27

Primary completion

2026-03-19

Completion

2026-03-19

Publications

• Van Nieuwenhuysen E, Vergote I, Randall LM, Tromp J, Lorusso D, O'Cearbhaill RE, Boere I, Pisano C, Sanchez LM, Banerjee S, Collins DC, Zikan M, Mathews C, Kummel J, Melichar B, Jackson AL, Madsen K, Gennigens C, Ottevanger N, Ghamande S, Salutari V, Baurain JF, Reyners AKL, Chisamore M, Conte U, Windfeld K, Geiger M, Hansen H, Denys H, Cibula D, Oaknin A, Van Gorp T, Monk BJ; innovaTV 205/ENGOT-cx8/GOG-3024 investigators. Tisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/ENGOT-cx8/GOG-3024 study. Gynecol Oncol. 2026 Apr;207S:3-13. doi: 10.1016/j.ygyno.2026.02.008.
• Vergote I, Van Nieuwenhuysen E, O'Cearbhaill RE, Westermann A, Lorusso D, Ghamande S, Collins DC, Banerjee S, Mathews CA, Gennigens C, Cibula D, Tewari KS, Madsen K, Kose F, Jackson AL, Boere IA, Scambia G, Randall LM, Sadozye A, Baurain JF, Gort E, Zikan M, Denys HG, Ottevanger N, Forget F, Mondrup Andreassen C, Eaton L, Chisamore MJ, Viana Nicacio L, Soumaoro I, Monk BJ. 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. J Clin Oncol. 2023 Dec 20;41(36):5536-5549. doi: 10.1200/JCO.23.00720. Epub 2023 Aug 31.

Drugs

Indications