A Trial of Tisotumab Vedotin in Cervical Cancer



Status:Recruiting
Conditions:Cervical Cancer, Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:June 12, 2018
End Date:April 2023
Contact:Genmab A/S Trial Information
Email:clinicaltrials@genmab.com
Phone:+4570202728

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

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

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.

Inclusion Criteria

- 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.

Exclusion Criteria

- 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
We found this trial at
26
sites
3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
Principal Investigator: Nicola Spirtos, Dr
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Shashikant Lele, Dr
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Brian Slomovitz, Dr
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Albuquerque, New Mexico 87102
Principal Investigator: Carolyn Muller, Dr
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Meaghan Tenney, Dr
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Birmingham, Alabama 35294
Principal Investigator: Charles Leath, Dr
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71 Langerei
Brugge, 8000
Principal Investigator: Eveline De Cuypere, Dr
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Camden, New Jersey
Principal Investigator: David Warshal, Dr
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Amanda Jackson, Dr
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Jayanthi Lea, Dr
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Greenville, South Carolina 29607
Principal Investigator: David Griffin, Dr
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Houston, Texas 77030
Principal Investigator: Joseph Lucci, Dr
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Indianapolis, Indiana 46219
Principal Investigator: Michael Method, Dr
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Indianapolis, Indiana 46256
Principal Investigator: Sumeet Bhatia, Dr.
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Jacksonville, Florida 32207
Principal Investigator: Jenny Whitworth, Dr
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Los Angeles, California 90095
Principal Investigator: Robin Farias-Eisner, Dr
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3991 Dutchmans Lane
Louisville, Kentucky 40202
Principal Investigator: Mary Gordinier, Dr
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680 Park Avenue West
Mansfield, Ohio 44906
Principal Investigator: David O'Malley, Dr
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Milwaukee, Wisconsin 53226
Principal Investigator: Willliam Bradley, Dr
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Oklahoma City, Oklahoma 73104
Principal Investigator: Camille Gunderson, Dr
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Phoenix, Arizona 85004
Principal Investigator: John Farley, Dr
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Phoenix, Arizona 85016
Principal Investigator: Bradley Monk, Dr
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Sacramento, California 95817
Principal Investigator: Edwin Alvarez, Dr
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Principal Investigator: Tashanna Myers, Dr
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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Tulsa, Oklahoma 74146
Principal Investigator: Michael Gold, Dr
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Willow Grove, Pennsylvania 19090
Principal Investigator: Mark Shahin, Dr
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