Ovarian CancerPhase 2NCT03657043
A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)
A Phase 2 study testing tisotumab vedotin in people with Ovarian Cancer and Fallopian Tube Cancer, run by Seagen Inc. at 37 sites in 6 countries.
Trial summary
This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- tisotumab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 37 sitesin 6 countries
- Study dates
- 20 Mar 2019to 8 Feb 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Safety run-in only: PROC. Patients may have received more than 1 prior systemic treatment regimen in the PROC setting.
- Part A and Part B only: Patients with PROC who have received 1 to 3 anticancer lines of therapy overall, including at least 1 line of therapy containing bevacizumab or biosimilar.
- Adjuvant ± neoadjuvant are considered 1 line of therapy.
- Patients may have received a PARP inhibitor or an immuno-oncology (IO) agent; any of these regimens are to be considered a line of therapy for the purposes of this study if not used as maintenance therapy.
- Maintenance therapy (including bevacizumab, PARP inhibitors and IOs) will be considered part of the preceding line of therapy and not to be counted as a new line of therapy.
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- Any chemotherapy regimen change due to toxicity in the absence of disease progression is considered as part of the same line of therapy.
- Hormonal therapy will be not be counted towards the lines of therapy.
- Measurable disease according to RECIST v1.1 as assessed by the investigator
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Life expectancy of at least 3 months
- Able to provide fresh or archival tissue for biomarker analysis
Who cannot join
- Primary platinum-refractory disease, defined as disease progression within 2 months of completion of first line platinum-based therapy
- Patients with clinical symptoms or signs of gastrointestinal obstruction with the past 6 months or who currently require parenteral nutrition
- Hematological: Known past or current coagulation defects leading to an increased risk of bleeding, diffuse alveolar hemorrhage from vasculitis, known bleeding diathesis, ongoing major bleeding, or trauma with increased risk of life-threatening bleeding within 8 weeks of trial entry
- Cardiovascular: Clinically significant cardiac disease including uncontrolled hypertension, unstable angina, acute myocardial infarction with 6 months of screening, serious cardiac arrhythmia requiring medication, medical history of congestive heart failure, or medical history of decreased cardiac ejection fraction of <45%
- Ophthalmological: Active ocular surface disease at baseline or prior episode of cicatricial conjunctivitis or Stevens Johnson syndrome
- Prior treatment with MMAE-derived drugs
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- Inflammatory bowel disease including Crohn's disease and ulcerative colitis
- Ongoing, acute, or chronic inflammatory skin disease
- Uncontrolled tumor-related pain
- Inflammatory lung disease requiring chronic medical therapy
- Grade 3 or higher pulmonary disease unrelated to underlying malignancy
- Uncontrolled pleural or pericardial effusions
- Grade >1 peripheral neuropathy
- Patients who are pregnant or breastfeeding
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
United States21 sites
Augusta University
Augusta, Georgia, 30912
University of Virginia
Charlottesville, Virginia, 22903
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic, The
Cleveland, Ohio, 44195
University of Missouri Healthcare / Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Ohio State University Clinical Trials Management Office
Columbus, Ohio, 43210
Texas Oncology - Fort Worth
Dallas, Texas, 75246
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Poudre Valley Health System (PVHS)
Fort Collins, Colorado, 80524
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Miami Cancer Institute- Plantation (MCIP)
Miami, Florida, 33176
Mount Sinai Chelsea
New York, New York, 10011
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Stanford Cancer Center South Bay
San Jose, California, 95124
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Renovatio Clinical
The Woodlands, Texas, 77380
University of Kansas Cancer Center
Westwood, Kansas, 66205
Spain6 sites
Hospital Universitario Vall d'Hebron
Barcelona, Other, 08035
L'Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Other, 08907
Hospital Universitario Ramon y Cajal
Madrid, Other, 28034
HM Centro Integral Oncologico Clara Campal
Madrid, Other, 28050
Clinica Universidad de Navarra
Pamplona, Other, 31008
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Other, 28223
Italy5 sites
Ospedale Ramazzini di Carpi
Carpi, Other, 41012
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Meldola, Other, 47014
Istituto Europeo di Oncologia
Milan, Other, 20141
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Other, 80131
Fondazione Policlinico Universitario Agostino
Rome, Other, 00168
Belgium2 sites
Algemeen Ziekenhuis Maria Middelares
Ghent, Other, 9000
Universitair Ziekenhuis Leuven
Lueven, Other, 3000
Ireland2 sites
Mater Private
Dublin, Other, D07 WKW8
Cork University Hospital
Wilton, Other, T12 E8YV
About this study
Official title: Open Label Phase 2 Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen
This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).
Read the detailed description
The study objectives are to evaluate the safety, antitumor activity, and pharmacokinetics of tisotumab vedotin (TV) administered every 3 weeks or on Days 1, 8, and 15 of every 4-week cycle (3Q4W) for patients with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has relapsed within 6 months of the completion of platinum-based treatment and determined to be platinum resistant. All patients must have PROC and be eligible for single agent chemotherapy.
The safety run-in period will evaluate the safety of a weekly schedule. The highest dose level that is considered safe will be the recommended phase 2 dose (RP2D) and will be used in Part A. In Part A, participants will be randomized in a 1:1 ratio to receive tisotumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisotumab vedotin on Days 1, 8, and 15 of every 4-week cycle (weekly regimen) at a pre-specified dose level, if the dose level is considered safe and tolerable in the safety run-in period.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- tisotumab vedotin
- Keywords
- Platinum-resistant, Antibody drug conjugate, Tisotumab vedotin, PROC, Seattle Genetics
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tisotumab vedotinDrug
Also called TIVDAK
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Safety Run-In (3Q4W Schedule) | Experimental | 28-day, 3 dose cycle Receives: Drug: tisotumab vedotin |
| Part A: Tisotumab Vedotin | Experimental | 21-day, single dose cycle Receives: Drug: tisotumab vedotin |
| Part A: Tisotumab Vedotin (3Q4W Schedule) | Experimental | 28-day, 3 dose cycle Receives: Drug: tisotumab vedotin |
| Part B: Tisotumab Vedotin (3Q4W Schedule) | Experimental | 28-day, 3 dose cycle Receives: Drug: tisotumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs) (Safety Run-In Only)
Incidence of dose-limiting toxicity (DLT) was evaluated in participants enrolled in the Safety Run-In, who were followed for protocol-defined DLT events up to 28 days after the first dose of tisotumab vedotin.
Measured: Up to 28 days
Confirmed Objective Response Rate (ORR) (Part B)
Proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Measured: Up to 9.7 months
Secondary outcomes (20)
Number of Participants With Adverse Events (AEs) (Part B)
An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
Measured: Up to 23.0 months
Confirmed and Unconfirmed ORR (Part B)
Proportion of participants who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator
Measured: Up to 9.7 months
Cancer Antigen 125 (CA-125) Response Rate According to Gynecologic Cancer Intergroup (GCIG) Criteria (Part B)
Percentage of participants who have at least a 50% reduction in CA-125 value from baseline
Measured: Up to 10.1 months
Overall Response According to the Gynecological Cancer Intergroup (GCIG) Combined RECIST and CA-125 Criteria (Part B)
Percentage of participants whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria
Measured: Up to 10.1 months
Duration of Response (DOR) (Part B)
Time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or death due to any cause, whichever comes first
Measured: Up to 8.3 months
Disease Control Rate (DCR) (Part B)
Percentage of participants who achieved a confirmed Complete Response(CR) or Partial Response (PR) per RECIST v1.1 as assessed by the investigator, or meet the Stable Disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks.
Measured: Up to 3.0 months
Time to Response (TTR) (Part B)
Time from the start of study treatment to the first documentation of objective response (CR or PR that is subsequently confirmed)
Measured: Up to 23.0 months
Progression-free Survival (PFS) (Part B)
Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first
Measured: Up to 9.7 months
Overall Survival (OS) (Part B)
Time from the start of study treatment to date of death due to any cause
Measured: Up to 23.0 months
Incidence of Antitherapeutic Antibodies (ATA) (Part B)
The proportion of participants who develop ATA at any time during the study. A positive baseline ATA result is considered positive post-baseline if the post-baseline ATA titer result is at least four times higher than the baseline result.
Measured: Up to 6.9 months
Pharmacokinetic (PK) Parameter: Antibody-Drug Conjugate (ADC) Maximum Concentration (Cmax) (Part B)
ADC Cmax was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: ADC Time of Cmax (Tmax) (Part B)
ADC Tmax was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: ADC Area Under Concentration-Time Curve (AUC) (Part B)
ADC AUC was derived from the PK blood samples collected.
Measured: Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose).
PK Parameter: Free Monomethyl Auristatin E (MMAE) Cmax (Part B)
MMAE Cmax was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: MMAE Tmax (Part B)
MMAE Tmax was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: MMAE AUC (Part B)
MMAE AUC was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: MMAE Trough Concentration (Ctrough) (Part B)
MMAE Ctrough was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: Total Antibody (TAb) Cmax (Part B)
TAb Cmax was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: TAb Tmax (Part B)
TAb Tmax was derived from the PK blood samples collected.
Measured: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: TAb Area Under Concentration-Time Curve (AUC) (Part B)
TAb AUC was derived from the PK blood samples collected.
Measured: Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start20 Mar 2019
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genmab
- Responsible party
- Sponsor
- Investigators
- Kristi Schmidt, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657043
- Sponsor's protocol ID
- SGNTV-002
- Status last verified
- Apr 2023
- First submitted
- 22 Aug 2018
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Feng S, Gunawan R, Passey C, Voellinger J, Polhamus D, Gerritsen A, O'Day C, Carret AS, Soumaoro I, Gupta M, Hanley WD. Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin. J Pharmacokinet Pharmacodyn. 2025 Oct 3;52(5):55. doi: 10.1007/s10928-025-10003-w.
PubMed 41044356
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase 2 Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen
- ClinicalTrials.gov ID
- NCT03657043
- Acronym / sponsor ID
- SGNTV-002
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- Platinum-resistant, Antibody drug conjugate, Tisotumab vedotin, PROC, Seattle Genetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genmab
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).
Detailed description
The study objectives are to evaluate the safety, antitumor activity, and pharmacokinetics of tisotumab vedotin (TV) administered every 3 weeks or on Days 1, 8, and 15 of every 4-week cycle (3Q4W) for patients with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has relapsed within 6 months of the completion of platinum-based treatment and determined to be platinum resistant. All patients must have PROC and be eligible for single agent chemotherapy.
The safety run-in period will evaluate the safety of a weekly schedule. The highest dose level that is considered safe will be the recommended phase 2 dose (RP2D) and will be used in Part A. In Part A, participants will be randomized in a 1:1 ratio to receive tisotumab vedotin intravenously (IV) every 3 weeks (Q3W regimen) or the safety run-in RP2D on Days 1, 8, and 15 of every 4-week cycle (weekly regimen; 3Q4W) if a RP2D has been identified. Participants who enroll in Part B will receive tisotumab vedotin on Days 1, 8, and 15 of every 4-week cycle (weekly regimen) at a pre-specified dose level, if the dose level is considered safe and tolerable in the safety run-in period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safety Run-In (3Q4W Schedule) | Experimental | Drug: tisotumab vedotin28-day, 3 dose cycle |
| Part A: Tisotumab Vedotin | Experimental | Drug: tisotumab vedotin21-day, single dose cycle |
| Part A: Tisotumab Vedotin (3Q4W Schedule) | Experimental | Drug: tisotumab vedotin28-day, 3 dose cycle |
| Part B: Tisotumab Vedotin (3Q4W Schedule) | Experimental | Drug: tisotumab vedotin28-day, 3 dose cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Safety run-in only: PROC. Patients may have received more than 1 prior systemic treatment regimen in the PROC setting.
- Part A and Part B only: Patients with PROC who have received 1 to 3 anticancer lines of therapy overall, including at least 1 line of therapy containing bevacizumab or biosimilar.
- Measurable disease according to RECIST v1.1 as assessed by the investigator
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Key exclusion criteria (14 listed)
- Primary platinum-refractory disease, defined as disease progression within 2 months of completion of first line platinum-based therapy
- Patients with clinical symptoms or signs of gastrointestinal obstruction with the past 6 months or who currently require parenteral nutrition
- Hematological: Known past or current coagulation defects leading to an increased risk of bleeding, diffuse alveolar hemorrhage from vasculitis, known bleeding diathesis, ongoing major bleeding, or trauma with increased risk of life-threatening bleeding within 8 weeks of trial entry
- Cardiovascular: Clinically significant cardiac disease including uncontrolled hypertension, unstable angina, acute myocardial infarction with 6 months of screening, serious cardiac arrhythmia requiring medication, medical history of congestive heart failure, or medical history of decreased cardiac ejection fraction of <45%
- Ophthalmological: Active ocular surface disease at baseline or prior episode of cicatricial conjunctivitis or Stevens Johnson syndrome
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: TIVDAKIntravenous (IV) infusion | Drug | Part A: Tisotumab Vedotin, Part A: Tisotumab Vedotin (3Q4W Schedule), Part B: Tisotumab Vedotin (3Q4W Schedule), Safety Run-In (3Q4W Schedule) |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs) (Safety Run-In Only)
Time frame: Up to 28 days
Incidence of dose-limiting toxicity (DLT) was evaluated in participants enrolled in the Safety Run-In, who were followed for protocol-defined DLT events up to 28 days after the first dose of tisotumab vedotin.
Confirmed Objective Response Rate (ORR) (Part B)
Time frame: Up to 9.7 months
Proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
20 secondary outcomes
Number of Participants With Adverse Events (AEs) (Part B)
Time frame: Up to 23.0 months
Confirmed and Unconfirmed ORR (Part B)
Time frame: Up to 9.7 months
Cancer Antigen 125 (CA-125) Response Rate According to Gynecologic Cancer Intergroup (GCIG) Criteria (Part B)
Time frame: Up to 10.1 months
Overall Response According to the Gynecological Cancer Intergroup (GCIG) Combined RECIST and CA-125 Criteria (Part B)
Time frame: Up to 10.1 months
Duration of Response (DOR) (Part B)
Time frame: Up to 8.3 months
Disease Control Rate (DCR) (Part B)
Time frame: Up to 3.0 months
Time to Response (TTR) (Part B)
Time frame: Up to 23.0 months
Progression-free Survival (PFS) (Part B)
Time frame: Up to 9.7 months
Overall Survival (OS) (Part B)
Time frame: Up to 23.0 months
Incidence of Antitherapeutic Antibodies (ATA) (Part B)
Time frame: Up to 6.9 months
Pharmacokinetic (PK) Parameter: Antibody-Drug Conjugate (ADC) Maximum Concentration (Cmax) (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: ADC Time of Cmax (Tmax) (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: ADC Area Under Concentration-Time Curve (AUC) (Part B)
Time frame: Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose).
PK Parameter: Free Monomethyl Auristatin E (MMAE) Cmax (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: MMAE Tmax (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: MMAE AUC (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: MMAE Trough Concentration (Ctrough) (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: Total Antibody (TAb) Cmax (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: TAb Tmax (Part B)
Time frame: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.
PK Parameter: TAb Area Under Concentration-Time Curve (AUC) (Part B)
Time frame: Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41044356Feng S, Gunawan R, Passey C, Voellinger J, Polhamus D, Gerritsen A, O'Day C, Carret AS, Soumaoro I, Gupta M, Hanley WD. Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin. J Pharmacokinet Pharmacodyn. 2025 Oct 3;52(5):55. doi: 10.1007/s10928-025-10003-w.
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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.
Kristi Schmidt, MD study director
Seagen Inc.
37 sites in 6 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 Ovarian Cancer and Fallopian Tube Cancer, run by Seagen Inc. at 37 sites in 6 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 12 inclusion and 14 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Spain, Italy, Belgium, Ireland and 1 more country. 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 6 May 2023). 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 With Dose-Limiting Toxicities (DLTs) (Safety Run-In Only) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03657043, which also lists 1 linked publication.
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 6 May 2023.