Overview

Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

Status:
Completed
Trial end date:
2019-01-10
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genmab
Seagen Inc.
Collaborator:
Genmab
Treatments:
Tisotumab vedotin
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.