Status:
COMPLETED
A Trial of Tisotumab Vedotin in Cervical Cancer
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Genmab
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03438396
Start Date
June 12 2018
End Date
August 2 2022
Last Update
July 25 2023
Active Locations (53)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Arizona Oncology Associate - Biltmore Cancer Center
Phoenix, Arizona, United States, 85016
3
UCLA Dept. of OBGYN
Los Angeles, California, United States, 90095
4
Southern Baptist Hospital of Florida, Inc
Jacksonville, Florida, United States, 32258