The purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).
Brian Slomovitz
Miami, Florida, United States
Johann de Bono
Chelsea, United Kingdom
Beatson Cancer Centre
Glasgow, United Kingdom
Fiona Thistlethwaite
Manchester, United Kingdom
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.
Time frame: Day 1 to Week 24 plus 30 days
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.
Time frame: Day 1 to Week 24 plus 30 days
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.
Time frame: Day 1 to Week 24 plus 30 days
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.
Time frame: Day 1 to Week 24 plus 30 days
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