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Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

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ClinicalTrials.gov Identifier: NCT03245736
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Genmab

Brief Summary:
The purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin.

Condition or disease Intervention/treatment Phase
Ovary Cancer Cervix Cancer Endometrium Cancer Bladder Cancer Prostate Cancer Esophagus Cancer Lung Cancer, Nonsmall Cell Squamous Cell Carcinoma of the Head and Neck Drug: Tisotumab Vedotin Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tisotumab Vedotin
All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles.
Drug: Tisotumab Vedotin
All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).




Primary Outcome Measures :
  1. Adverse events [ Time Frame: An expected average of 6 months ]
    Adverse events measured throughout the study from first treatment until end of trial



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • Therapeutic anti-coagulative or long-term anti-platelet treatment. Use of low dose acetylsalicylic acid (ASA) up to 81 mg/day and non-ASA nonsteroidal anti-inflammatory drugs (NSAID) is allowed.
  • 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.
  • Pregnant women must not take part in this trial and will be considered as screening failures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245736


Contacts
Contact: Rene Smrcka +4533447767 rsm@genmab.com

Locations
United States, Florida
Brian Slomovitz Recruiting
Miami, Florida, United States, 33136
Contact: Brian Slomovitz, Dr         
United Kingdom
Johann de Bono Recruiting
Chelsea, United Kingdom, SM2 5PT
Contact: Johann de Bono, Professor         
Beatson Cancer Centre Recruiting
Glasgow, United Kingdom
Principal Investigator: Robert Jones, Dr         
Fiona Thistlethwaite Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Fiona Thistlethwaite, Dr         
Sponsors and Collaborators
Genmab
Investigators
Study Director: Reshma Rangwala, Dr Genmab

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT03245736     History of Changes
Other Study ID Numbers: GCT1015-03
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Urinary Bladder Neoplasms
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases