A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)
Public ClinicalTrials.gov record NCT03657043. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03657043
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 19, 2019
- Primary completion
- Feb 7, 2022
- Completion
- Feb 7, 2022
- Last update posted
- May 5, 2023
2019 – 2022
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Cancer Center South Bay | San Jose | California | 95124 | — |
| Poudre Valley Health System (PVHS) | Fort Collins | Colorado | 80524 | — |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | — |
| Miami Cancer Institute- Plantation (MCIP) | Miami | Florida | 33176 | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | — |
| University of Missouri Healthcare / Ellis Fischel Cancer Center | Columbia | Missouri | 65212 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| 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 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | — |
| Ohio State University Clinical Trials Management Office | Columbus | Ohio | 43210 | — |
| Cleveland Clinic Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | — |
| Texas Oncology - Fort Worth | Dallas | Texas | 75246 | — |
| Renovatio Clinical | The Woodlands | Texas | 77380 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03657043, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03657043 live on ClinicalTrials.gov.