Evidence map›Paper›PMID 42467245›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026

Molecular Profiling of Tisotumab Vedotin-Treated Patients Identifies Immune Pathways Associated with Clinical Activity.

Sriram Sridhar, M Guy Roukens, Christina Y Yu, Tim Dielen, Berris van Kessel-Welmers, Han Si, Steven Xu, Lauren K Brady, Merzu Belete, Mark Bieda and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03438396 (A Single Arm, Multicenter, International Trial of Tisotumab Vedotin), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT03438396 phase2completednot on this map

A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer

TypeinterventionalSponsorSeagen Inc.Ran2018 to 2022Enrolled102ConditionsCervical CancerArmstisotumab vedotin
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

18 authors.

Sriram Sridhar *Genmab US, Inc., Plainsboro, New Jersey.ORCID 0009-0006-0679-4544
M Guy Roukens *Genmab B.V., Utrecht, the Netherlands.ORCID 0000-0002-4270-8678
Christina Y YuGenmab US, Inc., Plainsboro, New Jersey.ORCID 0000-0002-4165-6781
Tim DielenGenmab B.V., Utrecht, the Netherlands.ORCID 0009-0004-1369-9938
Berris van Kessel-WelmersGenmab B.V., Utrecht, the Netherlands.ORCID 0009-0009-9298-4820
Han SiGenmab US, Inc., Plainsboro, New Jersey.ORCID 0000-0001-5655-3374
Steven XuGenmab US, Inc., Plainsboro, New Jersey.ORCID 0000-0001-6997-5533
Lauren K BradyGenmab US, Inc., Plainsboro, New Jersey.ORCID 0009-0006-3012-8509
Merzu BeleteGenmab US, Inc., Plainsboro, New Jersey.ORCID 0000-0003-0183-3170
Mark BiedaPfizer Inc., Bothell, Washington.ORCID 0009-0009-3280-0911
Khyati N ShahPfizer Inc., South San Francisco, California.ORCID 0000-0002-2510-803X
Regina AquinoGenmab US, Inc., Plainsboro, New Jersey.ORCID 0009-0000-1239-0526
Denise GallagherGenmab US, Inc., Plainsboro, New Jersey.ORCID 0009-0003-9323-1798
Craig J ThalhauserGenmab US, Inc., Plainsboro, New Jersey.ORCID 0009-0008-8500-8277
Brandon W HiggsGenmab US, Inc., Plainsboro, New Jersey.ORCID 0000-0002-2951-0245
Mark FereshtehGenmab US, Inc., Plainsboro, New Jersey.ORCID 0009-0001-2919-8343
Maria Jure-KunkelGenmab US, Inc., Plainsboro, New Jersey.ORCID 0000-0002-3751-1934
Jeffrey R HarrisGenmab US, Inc., Plainsboro, New Jersey.ORCID 0009-0001-0761-8108

Funding

Genmab (Genmab A/S)
6 · The paper itself

Abstract

purposeTisotumab vedotin (TV) is a tissue factor (TF)-specific antibody-drug conjugate (ADC) that was evaluated in the innovaTV 204 study in patients with recurrent or metastatic cervical cancer (r/mCC). Although TF expression is required for TV binding to tumor cells, clinical responses were found to be independent of TF levels. This study aimed to evaluate whether baseline tumor gene expression signatures consistent with the proposed mechanisms of action of TV were associated with clinical outcomes. EXPERIMENTAL

designPretreatment tumor samples from patients enrolled in innovaTV 204 (NCT03438396), a phase II, single-arm, multicenter trial of TV in r/mCC following chemotherapy, were profiled for molecular biomarkers. Gene expression analyses of immune-related signatures were stratified by clinical response. In vitro antibody-dependent cellular phagocytosis (ADCP) and antibody-dependent cellular cytotoxicity (ADCC) assays were performed using tumor cell lines with variable TF expression.

resultsTF expression was confirmed in most patients but did not associate with response. Higher expression of gene signatures linked to natural killer (NK) cells and myeloid cells was associated with improved clinical outcomes. In vitro, TV induced tumor cell death through myeloid-mediated ADCP and NK-mediated ADCC across various TF expression levels.

conclusionsThis work provides supportive evidence for TV mechanisms of action that involve antitumor effects through direct cytotoxic and immune effector-mediated mechanisms. The association of immune-related gene signatures with improved clinical outcomes supports a multimodal mechanism of action for TV in the clinic and provides further rationale for ADC efficacy in tumors with heterogeneous target expression.

Indexed as

Antibodies, MonoclonalBiomarkers, TumorImmunoconjugatesUterine Cervical NeoplasmsAntibodies, Monoclonal, HumanizedAntibody-Dependent Cell CytotoxicityCell Line, TumorFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMiddle AgedOligopeptidesThromboplastinTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiomarkers, TumorImmunoconjugatesOligopeptidesThromboplastintisotumab vedotin

Identifiers

PMID42467245
PMCPMC13628103

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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.