# innovaTV 301 / ENGOT-cx12 / GOG-3057

Source: https://onco.cc/trials/innovatv-301/  
OnCo record `innovatv-301` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first ADC to extend life in cervical cancer, for women whose disease has come back after chemotherapy.

## Summary

innovaTV 301, also ENGOT-cx12 and GOG-3057, trial NCT04697628 sponsored by Genmab and Pfizer through Seagen and published in the New England Journal of Medicine in 2024, produced the first antibody-drug conjugate to extend life in cervical cancer, for women whose disease has returned after one or two lines including platinum. It randomised 502 patients to tisotumab vedotin or investigator's choice chemotherapy, met its primary overall survival endpoint, improved progression-free survival and tripled the response rate, leading to full FDA approval in April 2024; ocular events in about half, mostly conjunctivitis, plus neuropathy and bleeding require mitigation. OnCo links it to cervical cancer, antibody-drug conjugates, tissue factor as a target, tisotumab vedotin, Ignace Vergote and Bradley J. Monk. Whether the drug can move earlier or combine with immunotherapy is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04697628
- Phase: 3
- Setting: Recurrent or metastatic cervical cancer after 1-2 prior lines including platinum: tisotumab vedotin vs investigator's-choice chemotherapy
- Sponsor: Genmab / Pfizer (Seagen)
- Enrolled: 502
- Result: OS 11.5 vs 9.5 months (HR 0.70).
- Outcomes: Overall survival: Tisotumab vedotin 11.5 months vs Chemotherapy 9.5 months, HR 0.7; Progression-free survival: Tisotumab vedotin 4.2 months vs Chemotherapy 2.9 months, HR 0.67

## Sources

- ClinicalTrials.gov NCT04697628: https://clinicaltrials.gov/study/NCT04697628
- NEJM 2024: https://www.nejm.org/doi/full/10.1056/NEJMoa2313811

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [Tissue factor](https://onco.cc/targets/tissue-factor/)
- drugs: [Tisotumab vedotin](https://onco.cc/drugs/tisotumab-vedotin/)
- companies: [Genmab](https://onco.cc/companies/genmab/)
- people: [Bradley J. Monk](https://onco.cc/people/bradley-monk/), [Ignace Vergote](https://onco.cc/people/ignace-vergote/)
- key papers: [innovaTV 301: tisotumab vedotin versus chemotherapy as second- or third-line therapy for recurrent cervical cancer](https://onco.cc/key-papers/paper-innovatv-301-tisotumab-nejm-2024/)

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