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.
Tisotumab Vedotin
Squamous Cell Carcinoma of Head and Neck+46
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Johann de Bono
Chelsea, United KingdomBeatson Cancer Centre
Glasgow, United KingdomFiona Thistlethwaite
Manchester, United Kingdom