Evidence map›Paper›PMID 37651655›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

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.

Ignace Vergote, Els Van Nieuwenhuysen, Roisin E O'Cearbhaill, Anneke Westermann, Domenica Lorusso, Sharad Ghamande, Dearbhaile C Collins, Susana Banerjee, Cara A Mathews, Christine Gennigens and 21 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyClinical Trial, Phase I
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03786081 (A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin), which is not on this map. Cited by 51 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 4 pooled it
21.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03786081 phase1 / phase2terminatednot on this map

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer

TypeinterventionalSponsorSeagen, a wholly owned subsidiary of PfizerRan2019 to 2026Enrolled214ConditionsCervical CancerArmsTisotumab Vedotin, Bevacizumab, Pembrolizumab, Carboplatin
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 4 syntheses or guidelines pooled it, 73 citations in OpenAlex.

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  12. Antibody-Drug Conjugates in Gynecologic Oncology: Advances, Challenges, and Future Directions.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
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  15. Predictive Biomarkers of Antibody-Drug Conjugate Efficacy for Solid Tumors: Current Challenges and the Potential Role of Quantitative Proteomics.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 16 countries.

Ignace VergoteBelgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven Cancer Institute, Leuven, Belgium.ORCID 0000-0002-7589-8981
Els Van NieuwenhuysenBelgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven Cancer Institute, Leuven, Belgium.
Roisin E O'CearbhaillMemorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY.ORCID 0000-0001-8217-4554
Anneke WestermannDutch Gynaecological Oncology Group, Amsterdam University Medical Centers, Amsterdam, the Netherlands.ORCID 0000-0002-5588-7441
Domenica LorussoFondazione Policlinico Universitario Agostino Gemelli, IRCCS, Catholic University of Sacred Heart, Rome, Italy.ORCID 0000-0003-0981-0598
Sharad GhamandeDepartment of Obstetrics and Gynecology, Augusta University, Augusta, GA.
Dearbhaile C CollinsDepartment of Medical Oncology, Cancer Trials Ireland, Cork University Hospital, Cork, Ireland.ORCID 0000-0002-5156-0142
Susana BanerjeeRoyal Marsden National Health Service Foundation Trust, Institute of Cancer Research, London, United Kingdom.ORCID 0000-0002-8840-7934
Cara A MathewsProgram in Women's Oncology, Women & Infants Hospital, Legorreta Cancer Center at Alpert Medical School of Brown University, Providence, RI.ORCID 0000-0001-8461-4568
Christine GennigensBGOG, Centre Hospitalier Universitaire de Liège, Liège, Belgium.
David CibulaDepartment of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.ORCID 0000-0001-6387-9356
Krishnansu S TewariUniversity of California, Irvine, CA.ORCID 0000-0002-8417-7000
Kristine MadsenCentre for Cancer and Organ Diseases, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.
Fatih KöseBaskent University, Ankara, Turkey.
Amanda L JacksonDepartment of Obstetrics and Gynecology, University of Cincinnati Cancer Center, Cincinnati, OH.
Ingrid A BoereErasmus MC Cancer Institute, Rotterdam, the Netherlands.ORCID 0000-0002-4857-6346
Giovanni ScambiaFondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-9503-9041
Leslie M RandallSchool of Medicine, Virginia Commonwealth University, Richmond, VA.ORCID 0000-0003-3790-4858
Azmat SadozyeBeatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, United Kingdom.
Jean-François BaurainCliniques Universitaires Saint-Luc and Université Catholique de Louvain and BGOG, Brussels, Belgium.
Eelke GortUniversity Medical Center Utrecht, Utrecht, the Netherlands.ORCID 0000-0001-7390-0761
Michal ZikánFirst Faculty of Medicine, Bulovka University Hospital, Charles University, Prague, Czech Republic.
Hannelore G DenysBGOG, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0002-8897-9430
Nelleke OttevangerRadboudumc, Nijmegen, the Netherlands.ORCID 0000-0001-8209-487X
Frédéric ForgetBGOG, Centre Hospitalier de l'Ardenne-Site de Libramont, Libramont-Chevigny, Belgium.
Camilla Mondrup AndreassenGenmab A/S, Copenhagen, Denmark.
Lamar EatonGenmab US, Princeton, NJ.
Michael J ChisamoreMerck & Co, Inc, Rahway, NJ.
Leonardo Viana NicacioSeagen, Bothell, WA.
Ibrahima SoumaoroGenmab US, Princeton, NJ.
Bradley J MonkHonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ.ORCID 0000-0001-6985-0159
Agostino Gemelli University Polyclinic · ITCharles University · CZGenmab (United States) · USNational Health Service · GBThe European Academy of Gynaecological Surgery · BEAmsterdam University Medical Centers · NLAugusta University · USBaşkent University · TRBeatson West of Scotland Cancer Centre · GBCentre Hospitalier Universitaire de Liège · BECliniques Universitaires Saint-Luc · BECork University Hospital · IECreighton University · USErasmus MC Cancer Institute · NLGenmab (Denmark) · DKGhent University Hospital · BEMemorial Sloan Kettering Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USRadboud University Nijmegen · NLRigshospitalet · DK

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeTissue factor is highly expressed in cervical carcinoma and can be targeted by tisotumab vedotin (TV), an antibody-drug conjugate. This phase Ib/II study evaluated TV in combination with bevacizumab, pembrolizumab, or carboplatin for recurrent or metastatic cervical cancer (r/mCC).

methodsThis open-label, multicenter study (ClinicalTrials.gov identifier: NCT03786081) included dose-escalation arms that assessed dose-limiting toxicities (DLTs) and identified the recommended phase II dose (RP2D) of TV in combination with bevacizumab (arm A), pembrolizumab (arm B), or carboplatin (arm C). The dose-expansion arms evaluated TV antitumor activity and safety at RP2D in combination with carboplatin as first-line (1L) treatment (arm D) or with pembrolizumab as 1L (arm E) or second-/third-line (2L/3L) treatment (arm F). The primary end point of dose expansion was objective response rate (ORR).

resultsA total of 142 patients were enrolled. In dose escalation (n = 41), no DLTs were observed; the RP2D was TV 2 mg/kg plus bevacizumab 15 mg/kg on day 1 once every 3 weeks, pembrolizumab 200 mg on day 1 once every 3 weeks, or carboplatin AUC 5 on day 1 once every 3 weeks. In dose expansion (n = 101), the ORR was 54.5% (n/N, 18/33; 95% CI, 36.4 to 71.9) with 1L TV + carboplatin (arm D), 40.6% (n/N, 13/32; 95% CI, 23.7 to 59.4) with 1L TV + pembrolizumab (arm E), and 35.3% (12/34; 19.7 to 53.5) with 2L/3L TV + pembrolizumab (arm F). The median duration of response was 8.6 months, not reached, and 14.1 months, in arms D, E, and F, respectively. Grade ≥3 adverse events (≥15%) were anemia, diarrhea, nausea, and thrombocytopenia in arm D and anemia in arm F (none ≥15%, arm E).

conclusionTV in combination with bevacizumab, carboplatin, or pembrolizumab demonstrated manageable safety and encouraging antitumor activity in treatment-naive and previously treated r/mCC.

Indexed as

AnemiaLung NeoplasmsUterine Cervical NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinFemaleHumansNeoplasm Recurrence, LocalOligopeptidesAntibodies, Monoclonal, HumanizedBevacizumabCarboplatinOligopeptidespembrolizumabtisotumab vedotin

Identifiers

PMID37651655
PMCPMC10730069
OpenAlexW4386316303

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.