Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03245736|
Recruitment Status : Completed
First Posted : August 10, 2017
Results First Posted : November 4, 2021
Last Update Posted : November 4, 2021
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have either:
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- GEN702: Acceptable coagulation status defined as: INR ≤ 1.2 (without anticoagulant therapy), and aPTT ≤ ULN.
- Presence of CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 2 peripheral neuropathy.
Clinically significant active viral, bacterial or fungal infection requiring:
- Intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose in this trial, or
- Oral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial.
- Prophylactic anti-infective therapy, which is given without clinical symptoms is allowed.
- Ongoing acute or chronic inflammatory skin disease.
- Women who are breast feeding.
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|
Documents provided by Seagen Inc.:
|Responsible Party:||Seagen Inc.|
|Other Study ID Numbers:||
|First Posted:||August 10, 2017 Key Record Dates|
|Results First Posted:||November 4, 2021|
|Last Update Posted:||November 4, 2021|
|Last Verified:||October 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Squamous Cell Carcinoma of Head and Neck
Uterine Cervical Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Head and Neck Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Genital Diseases, Female
Digestive System Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms