Evidence map›Paper›PMID 35633184›Full record

Trial reportCancer science2022

Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study.

Kan Yonemori, Yasutoshi Kuboki, Kosei Hasegawa, Takashi Iwata, Hidenori Kato, Kazuhiro Takehara, Yasuyuki Hirashima, Hisamori Kato, Chaitali Passey, Jeppe Klint Buchbjerg and 5 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 7% 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.

NCT03913741 phase1 / phase2completednot on this map

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

TypeinterventionalSponsorGenmabRan2019 to 2021Enrolled23ConditionsSolid TumorArmstisotumab vedotin
NCT06558682 narecruitingnot on this mapstarted 2024, after this paper: background citation

Disitamab Vedotin Combined With Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer: a Prospective, Single-arm Clinical Trial

TypeinterventionalSponsorQilu Hospital of Shandong UniversityRan2024 to 2026Enrolled48ConditionsUterine Cervical NeoplasmsArmsDisitamab Vedotin and Cisplatin
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  16. Adverse events of antibody-drug conjugates on the ocular surface in cancer therapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
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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

15 authors at 10 institutions in 3 countries.

Kan YonemoriNational Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-7624-7611
Yasutoshi KubokiNational Cancer Center Hospital East, Chiba, Japan.
Kosei HasegawaSaitama Medical University International Medical Center, Saitama, Japan.
Takashi IwataKeio University School of Medicine, Tokyo, Japan.
Hidenori KatoNational Hospital Organization, Hokkaido Cancer Center, Sapporo, Japan.
Kazuhiro TakeharaNHO Shikoku Cancer Center, Matsuyama, Japan.ORCID https://orcid.org/0000-0001-8808-3338
Yasuyuki HirashimaShizuoka Cancer Center, Shizuoka, Japan.
Hisamori KatoKanagawa Cancer Center, Kanagawa, Japan.
Chaitali PasseyGenmab US, Inc., Princeton, New Jersey, USA.
Jeppe Klint BuchbjergGenmab A/S, Copenhagen, Denmark.
Jeffrey R HarrisGenmab US, Inc., Princeton, New Jersey, USA.
Camilla Mondrup AndreassenGenmab A/S, Copenhagen, Denmark.
Leonardo NicacioSeagen Inc., Bothell, WA, USA.
Ibrahima SoumaoroGenmab US, Inc., Princeton, New Jersey, USA.
Keiichi FujiwaraSaitama Medical University International Medical Center, Saitama, Japan.
Genmab (United States) · USGenmab (Denmark) · DKKanagawa Prefectural Hospital Organization · JPSaitama International Medical Center · JPKeio University · JPNational Cancer Center Hospital East · JPSeagen (United States) · USShikoku Cancer Center · JPShizuoka Cancer Center · JPTokyo National Hospital · JP

Funding

Genmab A/S (Copenhagen, Denmark) and Seagen Inc. (Bothell, USA)
6 · The paper itself

Abstract

New treatments, particularly second-line options, are needed to improve outcomes for patients with recurrent/metastatic cervical cancer (r/mCC). Tisotumab vedotin (TV) is an antibody-drug conjugate directed to tissue factor, a transmembrane protein commonly expressed in cancer cells, to deliver cytotoxic monomethyl auristatin E. This single-arm, open-label phase 1/2 trial evaluated the consistency of safety and efficacy outcomes of TV in Japanese patients with r/mCC to bridge the current findings with those reported in previous trials in non-Japanese patients in the United States and Europe. In part 1 (dose escalation; N = 6), patients with advanced solid tumors received TV 1.5 or 2.0 mg/kg once every 3 weeks to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 (dose expansion; N = 17) evaluated the RP2D in r/mCC patients with 1-2 prior lines of therapy. In part 1, no dose-limiting toxicities were observed, the MTD was not reached, and TV 2.0 mg/kg was established as the RP2D. In part 2, the most common treatment-emergent adverse events were anemia (58.8%), nausea (58.8%), alopecia (47.1%), epistaxis (47.1%), and diarrhea (35.3%); adverse events of special interest were bleeding (76.5%), ocular events (35.3%), and peripheral neuropathy (17.6%), and were mostly grade 1/2. In part 2, confirmed objective response rate was 29.4%, median duration of response was 7.1 months, and median time to response was 1.2 months. In Japanese patients with r/mCC, TV demonstrated a manageable and tolerable safety, pharmacokinetics, and efficacy profile consistent with that observed in non-Japanese patients.

Indexed as

ImmunoconjugatesUterine Cervical NeoplasmsAntibodies, Monoclonal, HumanizedFemaleHumansMaximum Tolerated DoseNeoplasm Recurrence, LocalOligopeptidesAntibodies, Monoclonal, HumanizedImmunoconjugatesOligopeptidestisotumab vedotinfemalerecurrencethromboplastintisotumab vedotinuterine cervical neoplasms

Identifiers

PMID35633184
PMCPMC9357646
OpenAlexW4281676819

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.