Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

October 6, 2021 updated by: Seagen Inc.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Chelsea, United Kingdom, SM2 5PT
        • Johann de Bono
      • Glasgow, United Kingdom
        • Beatson Cancer Centre
      • Manchester, United Kingdom, M20 4BX
        • Fiona Thistlethwaite
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Brian Slomovitz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).
Other Names:
  • TIVDAK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Time Frame: Day 1 to Week 24 plus 30 days
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.
Day 1 to Week 24 plus 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Day 1 to Week 24 plus 30 days
Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] criteria. The best overall response was reported for each participant.
Day 1 to Week 24 plus 30 days
Number of Participants With Increased Cancer Antigen (CA 125) Levels
Time Frame: Day 1 to Week 24 plus 30 days
The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.
Day 1 to Week 24 plus 30 days
Number of Participants With Increased Prostate Specific Antigen (PSA)
Time Frame: Day 1 to Week 24 plus 30 days
The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.
Day 1 to Week 24 plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Genmab

Investigators

  • Study Director: Medical Director, Genmab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2017

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCT1015-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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