Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
NCT04697628 · innovaTV 301 Phase 3Completed
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer (Industry)
- Enrollment
- 502 (actual)
- Start date
- 22 Feb 2021
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 15 Jan 2026
- Last update posted
- 24 Feb 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- tisotumab vedotin Drug
- topotecan Drug
- vinorelbine Drug
- gemcitabine Drug
- irinotecan Drug
- pemetrexed Drug
Conditions and primary outcome
- Cervical Cancer
Primary outcome
Overall Survival (From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months))
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04697628 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Overall Survival
- Time frame
- From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)
- Measure
- Median
- Unit
- Months
Tisotumab Vedotin vs ChemotherapySuperiority
- Estimate
- 0.70Cox Proportional Hazard
- 95% CI, two-sided
- 0.54 to 0.89
- p-value
- 0.0038
- Method
- Stratified log-rank test
Serious adverse events
Time frame: For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months)
| Group | Affected | At risk |
|---|---|---|
| Tisotumab Vedotin | 82 | 250 |
| Chemotherapy | 94 | 239 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
3 on PubMedPatient-reported outcomes with tisotumab vedotin versus chemotherapy in patients with recurrent or metastatic cervical cancer: post hoc analyses from the open-label, randomized, phase 3 ENGOT-cx12/GOG-3057/innovaTV 301 trial.
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2026 Aug 11
PubMed 42680635 (opens in a new tab)DOI 10.1016/j.ijgc.2026.104947 (opens in a new tab)
Tisotumab vedotin in Japanese patients with recurrent or metastatic cervical cancer: results from the innovaTV 301/ENGOT-cx12/GOG-3057 trial.
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2026 Apr
PubMed 41644383 (opens in a new tab)DOI 10.1016/j.ijgc.2025.104450 (opens in a new tab)
Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.
The New England journal of medicine · 2024 Jul 4
PubMed 38959480 (opens in a new tab)DOI 10.1056/NEJMoa2313811 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04697628 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.