Trial of efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) in patients with previously treated, advanced cervical cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

• Patients with extra-pelvic metastatic or recurrent cervical cancer with
squamous cell, adenocarcinoma or adenosquamous histology, that:
1. Have experienced disease progression during or after treatment with:
- Paclitaxel+cisplatin or carboplatin OR
- Paclitaxel+topotecan,
in combination with bevacizumab unless patients are ineligible for
bevacizumab treatment according to local standards.
2. Have received no more than 2 prior systemic treatment regimens for
recurrent or metastatic cervical cancer. Chemotherapy administered in
the adjuvant or neoadjuvant setting, or in combination with radiation
therapy should not be counted as a prior systemic treatment regimen.
3. Are not candidates for curative therapy, including but not limited to,
radiotherapy or exenterative surgery.
• Age = 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1
• Life expectancy of at least three months
• A negative serum pregnancy test for patients of reproductive potential
• Patients of reproductive potential must agree to use adequate
contraception during and for 6 months after the last IMP administration
• Following receipt of verbal and written information about the trial,
patients must provide signed informed consent before any trial-related
activity is carried out
• Acceptable coagulation status:
- For patients not on anti-coagulation therapy:
o Activated partial thromboplastin time (aPTT) = 1.25 ULN.
o International normalized ratio (INR) = 1.2.
- For patients on anti-coagulation therapy:
o aPTT = 1.25 ULN.
o INR:
*Patients on anti-coagulants that require laboratory
assessments for dose titration (warfarin or other Vitamin K dependent
anti-coagulant agents) must be on a steady dose (no active titration) for
4 weeks prior to first planned administration of tisotumab vedotin and
have an INR = 2.5 for eligibility.
*Patients on anti-coagulants that do not require laboratory
assessments for dose titration do not to be on a steady dose for > 4
weeks prior to first planned administration of tisotumab vedotin.
o Concurrent chronic use of prophylactic AcetylSalicylic Acid (ASA,
e.g., aspirin) is prohibited on any type of anti-coagulation therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

• Known past or current coagulation defects
• Ongoing major bleeding
• Clinically significant cardiac disease
• Other cancer: Known past or current malignancy other than inclusion
diagnosis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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