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innovaTV 204

Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6)

Phase 2N = 102NCT03438396

Population
Recurrent or metastatic squamous cell, adenocarcinoma or adenosquamous cervical cancer with progression on or after doublet chemotherapy with bevacizumab where eligible; two or fewer previous systemic regimens for recurrent or metastatic disease; measurable disease; ECOG performance status 0 or 1
Design
Multicentre, open-label, single-arm phase 2 study at 35 sites in Europe and the USA; tisotumab vedotin 2.0 mg/kg (maximum 200 mg) intravenously every 3 weeks until progression by independent review or unacceptable toxicity. Primary endpoint: confirmed objective response rate by RECIST v1.1 assessed by an independent review committee. Activity and safety analysed in patients who received at least one dose.
Primary endpoint
ORR
Arms
  • Tisotumab vedotin (experimental, n = 102): Tisotumab vedotin 2.0 mg/kg (maximum 200 mg) every 3 weeks
People
Coleman RL, senior author innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators, innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators
Show the numbers
Results reported for innovaTV 204
EndpointAnalysisTisotumab vedotinControlEffect
ORRTreated patients (n = 101)Confirmed objective response rate per RECIST v1.1 by independent review committeeprimarymedian follow-up 10 monthsColeman 202124% (16–33%)—102 patients enrolled, 101 received at least one dose. Seven (7%) complete responses and 17 (17%) partial responses. Median follow-up 10.0 months (IQR 6.1-13.0).
Results reported for innovaTV 204
EndpointAnalysisTisotumab vedotinControlEffect
ORRTreated patients (n = 101)Confirmed objective response rate per RECIST v1.1 by independent review committeeprimarymedian follow-up 10 monthsColeman 202124% (16–33%)—102 patients enrolled, 101 received at least one dose. Seven (7%) complete responses and 17 (17%) partial responses. Median follow-up 10.0 months (IQR 6.1-13.0).
Primary publication: Coleman RL, Lorusso D, Gennigens C, González-Martín A, Randall L, Cibula D, et al. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021;22(5):609-619. PubMedDOI

Appears in

Sources

  1. Coleman RL, Lorusso D, Gennigens C, González-Martín A, Randall L, Cibula D, et al. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021;22(5):609-619.

    PubMedDOI