A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factor

Phase 1

• Conditions: 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); MedDRA version: 20.0 Level: HLT Classification code 10014742 Term: Endometrial neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10008342 Term: Cervix carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10023774 Term: Large cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: SOC; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004743-37-BE
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

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 < 3.
oGEN702: Acceptable coagulation status defined as: INR = 1.2 (without
anticoagulant therapy), and aPTT = ULN.
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified