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: 19.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: HLT Classification code 10014742 Term: Endometrial neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: SOC; MedDRA version: 19.1 Level: PT Classification code 10008342 Term: Cervix carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 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: 19.1 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-20
• 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 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 or better.
- Patients must not have experienced disease progression or unmanageable toxicity.
- Patients must not have received any other anti-cancer treatment since the base trial.
- Investigator’s assessment that the benefit of continued tisotumab vedotin therapy will outweigh the risks.
- 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.
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

- Therapeutic anti-coagulative or long-term anti-platelet treatment (use of low dose acetylsalicylic acid [ASA] up to 81 mg/day and non-ASA nonsteroidal anti inflammatory drugs is allowed).
- 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 pregnant or breast feeding.

Study & Design

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