Completed

A Multi-center, Open-label Trial Investigating the Efficacy and Safety of Continued Treatment With Tisotumab Vedotin in Patients With Solid Tumors Known to Express Tissue Factor.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Tisotumab Vedotin

Drug
Who is being recruted

Squamous Cell Carcinoma of Head and Neck+46

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2017
See protocol details

Summary

Principal SponsorSeagen Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 23, 2017

Actual date on which the first participant was enrolled.

This is an open-label, multicenter trial to collect long-term safety and efficacy data and to provide ongoing access to tisotumab vedotin for patients with solid tumors who have completed a tisotumab vedotin base trial.

Official TitleA Multi-center, Open-label Trial Investigating the Efficacy and Safety of Continued Treatment With Tisotumab Vedotin in Patients With Solid Tumors Known to Express Tissue Factor.
NCT03245736
Principal SponsorSeagen Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckUrogenital DiseasesGenital DiseasesAdnexal DiseasesUrinary Bladder DiseasesUrinary Bladder NeoplasmsBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellUterine Cervical DiseasesUterine Cervical NeoplasmsDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsEsophageal DiseasesEsophageal NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersHead and Neck NeoplasmsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsProstatic DiseasesProstatic NeoplasmsRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsUterine DiseasesUterine NeoplasmsEndometrial NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

Inclusion Criteria: * Patients must have either: 1. completed the base trial and have shown a clinical benefit of SD or better and have never met any withdrawal criteria as defined in the tisotumab vedotin base protocol, or 2. not completed treatment as defined in the base protocol for reasons that are not considered critical and unmanageable for the safety of the patient (as evaluated by the investigator and/or the sponsor) and the patient clearly showed response of PR or better. * Patients must not have experienced radiographic disease progression or clinical signs of symptoms of instability requiring urgent intervention. * Patients must not have received any other anti-cancer treatment (including surgery, radiation or systemic chemotherapy) since the base trial. * Acceptable renal function * Acceptable liver function * Acceptable hematological status * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * A negative serum pregnancy test (if female and aged between 18-55 years old). * Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of tisotumab vedotin. 1. Adequate contraception for women is defined as hormonal birth control or an intrauterine device (safe hormonal contraceptives include contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). In countries where two highly effective methods of contraception are required this will be an inclusion criterion. 2. Male patients must be willing to use a latex condom during any sexual contact with females of childbearing potential during and for six months after the last infusion of tisotumab vedotin, even after having undergone a successful vasectomy. 3. In order to be considered as sterilized or infertile, a patient must have undergone surgical sterilization (vasectomy/bilateral tubectomy; hysterectomy and bilateral ovariectomy) or be postmenopausal (12 months or more with no period prior to enrolment). * Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out. * Acceptable coagulation status as defined in the applicable base protocol 1. GEN701: Acceptable coagulation status: International normalized ratio (INR) ≤ 1.2 (without anticoagulant therapy), and activated partial thromboplastin time (aPTT) ≤ 1.25 ULN; patients on stable doses of therapeutic anti-coagulative treatment for ≥ 8 weeks (e.g., warfarin) must have an INR \< 3. 2. GEN702: Acceptable coagulation status defined as: INR ≤ 1.2 (without anticoagulant therapy), and aPTT ≤ ULN. Exclusion Criteria: * Presence of CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 2 peripheral neuropathy. * Clinically significant active viral, bacterial or fungal infection requiring: 1. Intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose in this trial, or 2. Oral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial. 3. Prophylactic anti-infective therapy, which is given without clinical symptoms is allowed. * Ongoing acute or chronic inflammatory skin disease. * Women who are breast feeding.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Brian Slomovitz

Miami, United StatesOpen Brian Slomovitz in Google Maps
Suspended

Johann de Bono

Chelsea, United Kingdom
Suspended

Beatson Cancer Centre

Glasgow, United Kingdom
Suspended

Fiona Thistlethwaite

Manchester, United Kingdom
Completed4 Study Centers