Cancer of the ovary, cervix, endometrium, bladder, prostate (castrationresistant prostate cancer [CRPC]), esophagus, lung (non-small cell lung cancer [NSCLC]), and Squamous cell carcinoma of the head and neck (SCCHN) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) Med
Conditions
Interventions
Product Name: Tisotumab vedotin
Product Code: IgG1-1015-011-1006
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed I
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must have completed one of the base trials and have shown a clinical benefit of stable disease (SD) or better and have never met any withdrawal criteria as defined in the tisotumab vedotin base protocol, or not completed treatment as defined in the base protocol for reasons that are not considered critical and unmanageable for the safety of the patient (as evaluated by the investigator and/or the sponsor) and the patient clearly showed response of partial response (PR) or better. - Patients must not have experienced radiographic disease progression or clinical signs of symptoms of instability requiring urgent intervention. - Patients must not have received any other anti-cancer treatment (including surgery, radiation or systemic chemotherapy) since the base trial. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - A negative serum pregnancy test (if female and aged between 18-55 years old). - Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of tisotumab vedotin. - 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 as defined in the applicable base protocol: oGEN701: Acceptable coagulation status: International normalized ratio (INR) = 1.2 (without anticoagulant therapy), and activated partial thromboplastin time (aPTT) = 1.25 ULN; patients on stable doses of therapeutic anti-coagulative treatment for = 8 weeks (e.g., warfarin) must have an INR =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: - Presence of CTCAE (Common Toxicity Criteria for Adverse Events) grade = 2 peripheral neuropathy. - Clinically significant active viral, bacterial or fungal infection requiring intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose in this trial, or oral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial; prophylactic anti-infective therapy which is given without clinical symptoms is allowed. - Ongoing acute or chronic inflammatory skin disease. - Women who are breast feeding.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): objective response rate assessed measured by tumor shrinkage (according to Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] including change in PSA for patients with prostate cancer or CA 125 for patients with ovarian cancer. ;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect long-term safety data from patients with solid tumors who have been treated with tisotumab vedotin and completed any base trial (i.e., GEN701 or GEN702) ;Secondary Objective: To further evaluate the anti-tumor activity of tisotumab vedotin.;Primary end point(s): Adverse events.;Timepoint(s) of evaluation of this end point: During the entire study. | — |
Countries
Belgium, Denmark, Hungary, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Genmab A/S
Outcome results
None listed