recurrent or metastatic cervical cancer MedDRA version: 21.1 Level: PT Classification code 10008342 Term: Cervix carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Determine the anti-tumor efficacy in patients with cervical cancer;Secondary Objective: • Evaluate tumor response durability • Evaluate clinical response • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Duration of response (DOR) based upon RECIST v1.1 • Confirmed objective response rate based upon RECIST v1.1 assessed by the investigator • Time to response based upon RECIST v1.1 • Progression free survival based upon RECIST v1.1 • Overall survival • Adverse events and safety laboratory parameters • Pharmacokinetics (PK) • Immunogenicity ;Timepoint(s) of evaluation of this end point: • During the trial, see protocol | — |
Countries
Belgium, Czechia, Czech Republic, Denmark, Germany, Italy, Spain, Sweden, United States
Contacts
Public ContactClinical Trial Information
Genmab A/S
Outcome results
None listed