Clinical trial · Interventional
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| tisotumab vedotin | Drug | Tisotumab Vedotin | ALIAS |
| topotecan | Drug | Topotecan | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tisotumab vedotin
- description
- Tisotumab vedotin monotherapy
- interventionNames
- Drug: tisotumab vedotin
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
- interventionNames
- Drug: topotecan
- Drug: vinorelbine
- Drug: gemcitabine
- Drug: irinotecan
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and: * Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: * paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or * paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or * paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent * Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required. * Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted. * Measurable disease according to RECIST v1.1 as assessed by the investigator. * Has ECOG performance status of 0 or 1 prior to randomization. * Has life expectancy of at least 3 months. Exclusion Criteria * Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above. * Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry. * Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \>1 month prior to screening is allowed). * Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion. * Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration. * Peripheral neuropathy ≥grade 2. * Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
References
Publications (3)
- DERIVEDJordan SE, Gonzalez-Martin A, Morlock R, Hubig L, Yonemori K, Eberst L, Zikan M, Kim HS, Banerjee S, Damian F, Salutari V, Henry S, Raimondo M, Kolinsky M, Woelber L, Tromp J, Hietanen S, Nishio S, Lee JY, Manso L, Cruz F, Barraclough L, Oaknin A, Van Nieuwenhuysen E, Randall L, Lo SH, Mutebi A, Abrahami D, Leary A, Vergote I. Patient-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. Int J Gynecol Cancer. 2026 Aug 11:104947. doi: 10.1016/j.ijgc.2026.104947. Online ahead of print. PMID 42680635
- DERIVEDYonemori K, Nishio S, Suzuki S, Hasegawa K, Yunokawa M, Yamaguchi S, Okamoto A, Nakamura K, Kamiura S, Fujiwara K, Katsumata N, Kobayashi H, Usami T, Mochizuki A, Takehara K, Whalley E, Noguchi H, Soumaoro I, Slomovitz B, Vergote I. Tisotumab vedotin in Japanese patients with recurrent or metastatic cervical cancer: results from the innovaTV 301/ENGOT-cx12/GOG-3057 trial. Int J Gynecol Cancer. 2026 Apr;36(4):104450. doi: 10.1016/j.ijgc.2025.104450. Epub 2025 Dec 31. PMID 41644383
- DERIVEDVergote I, Gonzalez-Martin A, Fujiwara K, Kalbacher E, Bagameri A, Ghamande S, Lee JY, Banerjee S, Maluf FC, Lorusso D, Yonemori K, Van Nieuwenhuysen E, Manso L, Woelber L, Westermann A, Covens A, Hasegawa K, Kim BG, Raimondo M, Bjurberg M, Cruz FM, Angelergues A, Cibula D, Barraclough L, Oaknin A, Gennigens C, Nicacio L, Teng MSL, Whalley E, Soumaoro I, Slomovitz BM; innovaTV 301/ENGOT-cx12/GOG-3057 Collaborators. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med. 2024 Jul 4;391(1):44-55. doi: 10.1056/NEJMoa2313811. PMID 38959480