Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245736
• Other study ID #: GCT1015-03
• Status: Completed
• Phase: Phase 2
• Start date: August 23, 2017
• Est. completion date: January 10, 2019

Study information

• Verified date: October 2021
• Source: Seagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Non-Small-Cell Lung
• Cervix Cancer
• Endometrial Neoplasms
• Endometrium Cancer
• Esophageal Neoplasms
• Esophagus Cancer
• Lung Cancer, Nonsmall Cell
• Ovarian Neoplasms
• Ovary Cancer
• Prostate Cancer
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck
• Uterine Cervical Neoplasms

Intervention

Drug:
• Tisotumab Vedotin
All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).

Locations

Country	Name	City	State
United Kingdom	Johann de Bono	Chelsea
United Kingdom	Beatson Cancer Centre	Glasgow
United Kingdom	Fiona Thistlethwaite	Manchester
United States	Brian Slomovitz	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Seagen Inc.	Genmab

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)	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	Objective Response Rate	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
Secondary	Number of Participants With Increased Cancer Antigen (CA 125) Levels	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
Secondary	Number of Participants With Increased Prostate Specific Antigen (PSA)	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