Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGOG Foundation
About this trial
This is an open-label, single arm, phase 2 study designed to evaluate the efficacy of tisotumab vedotin in participants with recurrent or metastatic squamous cell carcinoma of the vulva by estimating the objective response rate.
Patients will receive tisotumab vedotin every 3 weeks (21 days plus or minus 3 days). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, or considered an adult by local regulations, at time of consent.
Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedures.
Has not received more than 2 prior systemic therapy regimens for recurrent and/or metastatic vulva cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as separate systemic therapy regimen.
Is not a candidate for curative therapy, including but not limited to radiotherapy or exenterative surgery.
Disqualifiers
Has primary melanoma, adenocarcinoma, sarcomatoid, or other histologies not mentioned in inclusion criterion 3
Known past or current coagulation defects leading to an increased risk of bleeding
Diffuse alveolar hemorrhage from vasculitis
Known bleeding diathesis
Trial design
Design model
Single group
Treatments tested in this trial
Tisotumab Vedotin
DrugTisotumab vedotin is an antibody-drug conjugate (ADC) directed against tissue factor (TF) and is composed of an IgG1 human monoclonal antibody chemically conjugated via a protease cleavable valine citrulline linker to the drug MMAE.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Tisotumab vedotinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate
Complete or partial objective tumor response as measured by CT scan, PET-CT or MRI and assessed by RECIST v. 1.1 criteria
Time frame
Measured from study enrollment then every 9 weeks for the first 36 weeks and then every 12 weeks thereafter through disease progression or completion of treatment assessed up to 5 years or study closure.Secondary outcomes
1
Nature and Degree of Adverse Events (Safety and Toxicity)
Nature and degree of adverse events as assessed using CTCAE v6 including frequencies and maximum grade by term and category
Time frame
Measured from the time of the first dose of study treatment until 30 days after the last dose of study treatment.2
Progression Free Survival
Progression-Free Survival (PFS) is defined as the duration of time from study enrollment to time of progression or death, whichever occurs first. Disease progression will be measured by CT scan, PET-CT or MRI and assessed per RECIST 1.1.
Time frame
Measured from study enrollment then every 9 weeks for the first 36 weeks and then every 12 weeks thereafter until time of documented disease progression or death, whichever occurs first assessed up to 5 years or study closure.3
Overall Survival
Overall survival (OS) is defined as the duration of time from the start of study treatment to time of death or the date of last contact.
Time frame
Measured from study enrollment to time of death or the date of last contact assessed up to 5 years or study closure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
GOG Foundation
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: