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
- 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: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10014742Term: Endometrial neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10008342Term: Cervix carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10023774Term: Large cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2016-004743-37-GB
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Objective response rate assessed measured by tumour shrinkage (according to Response Evaluation Criteria in Solid Tumours 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.