A Trial of Tisotumab Vedotin in Cervical Cancer

Completed · Phase 2

Conditions studied: Cervical Cancer

In brief

A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

Key facts

Study ID

NCT03438396

Run by

Seagen Inc.

People needed

102

Starts

2018-06-12

Expected to finish

2022-08-02

Last updated by the study team

2023-07-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.
• Measurable disease according to RECIST v1.1 as assessed by IRC.
• Age ≥ 18 years.
• Acceptable renal function
• Acceptable liver function
• Acceptable hematological status
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• A negative serum pregnancy test for patients of reproductive potential.
• All patients must provide a fresh or archival biopsy during screening.
• Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.

You may not qualify if…

• Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
• Known past or current coagulation defects leading to an increased risk of bleeding;
• Ongoing major bleeding
• Active ocular surface disease
• Known past or current malignancy other than the inclusion diagnosis.
• Peripheral neuropathy grade ≥ 2

Where it is running

• Arizona Oncology Associate - Biltmore Cancer Center — Phoenix, Arizona, United States
• UCLA Dept. of OBGYN — Los Angeles, California, United States
• Southern Baptist Hospital of Florida, Inc — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Gynecologic Oncology — Atlanta, Georgia, United States
• Community Hospital East — Indianapolis, Indiana, United States
• Louisville Oncology — Louisville, Kentucky, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Women's Cancer Center of Nevada — Las Vegas, Nevada, United States
• MD Anderson Cancer Center at Cooper University Hospital — Camden, New Jersey, United States
• University of New Mexico Comprehensive Cancer Center (UNMCCC) — Albuquerque, New Mexico, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Ohio State University Wexner Medical Center — Hilliard, Ohio, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa, Oklahoma, United States
• Abington Memorial Hospital — Willow Grove, Pennsylvania, United States
• Bon Secours Saint Francis Cancer Center — Greenville, South Carolina, United States
• UT Health McGovern Medical School — Houston, Texas, United States
• Froedtert & Medical College Clinics — Milwaukee, Wisconsin, United States
• AZ Sint-Jan Brugge-Oostende av — Bruges, Belgium
• Cliniques universitaires Saint-Luc — Brussels, Belgium
• Grand Hôpital de Charleroi — Charleroi, Belgium
• Algemeen Ziekenhuis Maria MiddelaresMedical Oncology - IKG — Ghent, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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