Ovary CancerPhase 2NCT03245736
Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.
A Phase 2 study testing Tisotumab Vedotin in people with Ovary Cancer and Cervix Cancer, run by Seagen Inc. at 4 sites in 2 countries.
Trial summary
The purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovary Cancer, Cervix Cancer, Endometrium Cancer
- What is being tested?
- Tisotumab Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Aug 2017to 10 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
Johann de Bono
Chelsea, SM2 5PT
Beatson Cancer Centre
Glasgow
Fiona Thistlethwaite
Manchester, M20 4BX
About this study
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.
The purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin.
Read the 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.
- Conditions
- Ovary Cancer, Cervix Cancer, Endometrium Cancer, Bladder Cancer, Prostate Cancer, Esophagus Cancer
- Being tested
- Tisotumab Vedotin
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms, Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisotumab VedotinDrug
Also called TIVDAK
All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).
| Study group | Role | What they receive |
|---|---|---|
| Tisotumab Vedotin | Experimental | All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles. Receives: Drug: Tisotumab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Week 24 plus 30 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Week 24 plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start23 Aug 2017
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genmab
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245736
- Sponsor's protocol ID
- GCT1015-03
- Status last verified
- Oct 2021
- First submitted
- 8 Aug 2017
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03245736
- Acronym / sponsor ID
- GCT1015-03
- Conditions
- Ovary Cancer, Cervix Cancer, Endometrium Cancer, Bladder Cancer, Prostate Cancer, Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genmab
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tisotumab Vedotin | Experimental | Drug: Tisotumab VedotinAll patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have either:
- 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
Key exclusion criteria (7 listed)
- Presence of CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 2 peripheral neuropathy.
- Clinically significant active viral, bacterial or fungal infection requiring:
- Ongoing acute or chronic inflammatory skin disease.
- Women who are breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tisotumab VedotinAlso: TIVDAKAll patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC). | Drug | Tisotumab Vedotin |
Primary outcome
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.
3 secondary outcomes
Objective Response Rate
Time frame: Day 1 to Week 24 plus 30 days
Number of Participants With Increased Cancer Antigen (CA 125) Levels
Time frame: Day 1 to Week 24 plus 30 days
Number of Participants With Increased Prostate Specific Antigen (PSA)
Time frame: Day 1 to Week 24 plus 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Genmab
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tisotumab Vedotin in people with Ovary Cancer and Cervix Cancer, run by Seagen Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE) (time frame: Day 1 to Week 24 plus 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.