Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

NCT ID: NCT03245736

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2019-01-10

Brief Summary

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

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.

Conditions

Ovary Cancer; Cervix Cancer; Endometrium Cancer; Bladder Cancer; Prostate Cancer; Esophagus Cancer; Lung Cancer, Nonsmall Cell; Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tisotumab Vedotin

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

Group Type: EXPERIMENTAL

Tisotumab Vedotin

Intervention Type: DRUG

All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).

Interventions

Tisotumab Vedotin

All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).

Intervention Type: DRUG

Other Intervention Names

TIVDAK

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genmab

INDUSTRY

Sponsor Role: collaborator

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Genmab

Locations

Brian Slomovitz

Miami, Florida, United States

Johann de Bono

Chelsea, , United Kingdom

Beatson Cancer Centre

Glasgow, , United Kingdom

Fiona Thistlethwaite

Manchester, , United Kingdom

Countries

United States; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GCT1015-03

Identifier Type: -

Identifier Source: org_study_id