TriangleNCT03245736 · CITED IN SOURCE DOCUMENTS
Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2021-11-04
The purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Objective Response Rate
Number of Participants With Increased Cancer Antigen (CA 125) Levels
Number of Participants With Increased Prostate Specific Antigen (PSA)
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles.
- intervention Names
- Drug: Tisotumab Vedotin
- label
- Tisotumab Vedotin
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Tisotumab Vedotin
- description
- All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).
- name
- Tisotumab Vedotin
- other Names
- TIVDAK
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 5
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
- time Frame
- Day 1 to Week 24 plus 30 days
- secondary Outcomes
- description
- 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.
- measure
- Objective Response Rate
- time Frame
- Day 1 to Week 24 plus 30 days
- description
- The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.
- measure
- Number of Participants With Increased Cancer Antigen (CA 125) Levels
- time Frame
- Day 1 to Week 24 plus 30 days
- description
- The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.
- measure
- Number of Participants With Increased Prostate Specific Antigen (PSA)
- time Frame
- Day 1 to Week 24 plus 30 days
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- occurrences
- context exact
- one dose of TIVDAK at 2 mg/kg intravenously every 3 weeks in innovaTV 301, innovaTV 204, innovaTV 201 (NCT02001623), innovaTV 202 (NCT02552121), innovaTV 203 (NCT03245736), and innovaTV 206 (NCT03913741). The median duration of treatment with TIVDAK was 3.7 months (range: 0.4-40.2). In this pooled safety population, the most com
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Preserved source evidence · Not medical advice