Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.
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|ClinicalTrials.gov Identifier: NCT03245736|
Recruitment Status : Completed
First Posted : August 10, 2017
Results First Posted : November 4, 2021
Last Update Posted : November 4, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||January 10, 2019|
|Actual Study Completion Date :||January 10, 2019|
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 Name: TIVDAK
- 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.
- 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.
- 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.
- 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.
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
|United States, Florida|
|Miami, Florida, United States, 33136|
|Johann de Bono|
|Chelsea, United Kingdom, SM2 5PT|
|Beatson Cancer Centre|
|Glasgow, United Kingdom|
|Manchester, United Kingdom, M20 4BX|
|Study Director:||Medical Director||Genmab|