Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.
Condition: Ovary Cancer; Cervix Cancer; Endometrium Cancer; Bladder Cancer; Prostate Cancer; Esophagus Cancer; Lung Cancer, Nonsmall Cell; Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Squamous Cell Carcinoma of Head and Neck; Uterine Cervical Neoplasms; Esophageal Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Endometrial Neoplasms
Intervention: Tisotumab Vedotin
Intervention description: All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).
Intervention MeSH terms: Tisotumab vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the trial is to evaluate efficacy and safety of continued treatment with
      tisotumab vedotin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have either:

               1. completed the base trial and have shown a clinical benefit of SD or better and
                  have never met any withdrawal criteria as defined in the tisotumab vedotin base
                  protocol, or

               2. 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 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.

          -  Acceptable renal function

          -  Acceptable liver function

          -  Acceptable hematological status

          -  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.

               1. Adequate contraception for women is defined as hormonal birth control or an
                  intrauterine device (safe hormonal contraceptives include contraceptive pills,
                  implants, transdermal patches, hormonal vaginal devices or injections with
                  prolonged release). In countries where two highly effective methods of
                  contraception are required this will be an inclusion criterion.

               2. Male patients must be willing to use a latex condom during any sexual contact
                  with females of childbearing potential during and for six months after the last
                  infusion of tisotumab vedotin, even after having undergone a successful
                  vasectomy.

               3. In order to be considered as sterilized or infertile, a patient must have
                  undergone surgical sterilization (vasectomy/bilateral tubectomy; hysterectomy and
                  bilateral ovariectomy) or be postmenopausal (12 months or more with no period
                  prior to enrolment).

          -  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

               1. GEN701: 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 < 3.

               2. GEN702: Acceptable coagulation status defined as: INR ≤ 1.2 (without
                  anticoagulant therapy), and aPTT ≤ ULN.

        Exclusion Criteria:

          -  Presence of CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 2
             peripheral neuropathy.

          -  Clinically significant active viral, bacterial or fungal infection requiring:

               1. Intravenous treatment with anti-infective therapy that has been administered less
                  than two weeks prior to first dose in this trial, or

               2. Oral treatment with anti-infective therapy that has been administered less than
                  one week prior to first dose in this trial.

               3. Prophylactic anti-infective therapy, which is given without clinical symptoms is
                  allowed.

          -  Ongoing acute or chronic inflammatory skin disease.

          -  Women who are breast feeding.