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NCT03657043 · ClinicalTrials.gov registry record · Phase 2

A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)

A Phase 2 study, sponsored by Seagen.

Completed
Registry status
Phase 2
Development phase
98
Enrollment target

NCT03657043: Completed Phase 2 study, sponsored by Seagen.

NCT03657043 is a Phase 2 study that has completed, run by Seagen. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03657043, a Phase 2 study, has completed, sponsored by Seagen.

COMPLETED
Registry status
Phase 2
Development phase
98 participants
Enrollment target

Study 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. 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).

Primary Outcome

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.

Interventions

  • DRUG tisotumab vedotin

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2019-03-20
Est. Completion 2022-02-08
Phase Phase 2
Seagen

84 total trials

What the finished NCT03657043 record still lists

NCT03657043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).

The record links to 0 conditions, and to 1 intervention - of which tisotumab vedotin is the first listed.

NCT03657043 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03657043 about?

NCT03657043 is a clinical study titled "A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)". 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...

What is the current status of trial NCT03657043?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2019-03-20. Estimated completion is 2022-02-08.

What interventions are being tested in trial NCT03657043?

The interventions under investigation include: tisotumab vedotin (DRUG).

Who is sponsoring clinical trial NCT03657043?

This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03657043's enrollment target sits among peer trials

98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03657043, the US trial registry maintained by the National Library of Medicine. NCT03657043 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.