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 including 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 combination with radiation therapy is not considered a prior systemic 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:
o International normalized ratio (INR) = 1.2 (without anti-coagulation therapy).
o Activated partial thromboplastin time (aPTT) = 1.25 ULN.
o Patients on anti-coagulation therapy (e.g., warfarin) must be on a steady dose (no active titration) for at least 4 weeks prior to screening and must have an INR = 2.5 for eligibility. Concurrent use of prophylactic AcetylSalicylic Acid (ASA, e.g., aspirin) for patients on anti-coagulation therapy (e.g., warfarin) is prohibited.
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
Main Objective: • Determine the anti-tumor efficacy in patients with cervical cancer;Secondary Objective: • Evaluate durability<br>• Evaluate other clinical outcomes<br>• Assess safety and tolerability;Primary end point(s): • Confirmed objective response rate based upon RECIST v1.1 assessed by the independent review committee;Timepoint(s) of evaluation of this end point: • During the trial, see protocol

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Duration of response (DOR) based upon RECIST v1.1<br>• Confirmed objective response rate based upon RECIST v1.1 assessed by the investigator<br>• Time to response based upon RECIST v1.1<br>• Progression free survival based upon RECIST v1.1<br>• Overall survival<br>• Adverse events and safety laboratory parameters<br>• Pharmacokinetics (PK)<br>• Immunogenicity;Timepoint(s) of evaluation of this end point: • During the trial, see protocol

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