Trials / Completed
CompletedNCT03438396
A Trial of Tisotumab Vedotin in Cervical Cancer
A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
Detailed description
The purpose of the trial is to evaluate the efficacy and safety/tolerability of tisotumab vedotin in patients with previously treated, recurrent or metastatic cervical cancer. Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of tumors including cervical cancer. Preliminary safety and efficacy data observed in a cohort of previously treated cervical cancer patients suggest a positive benefit risk profile for this population of high unmet need.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tisotumab vedotin | All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity |
Timeline
- Start date
- 2018-06-12
- Primary completion
- 2020-02-06
- Completion
- 2022-08-02
- First posted
- 2018-02-19
- Last updated
- 2023-07-25
- Results posted
- 2021-11-04
Locations
53 sites across 8 countries: United States, Belgium, Czechia, Denmark, Germany, Italy, Spain, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03438396. Inclusion in this directory is not an endorsement.