Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Prostatic Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Lung Neoplasms

Ovarian Neoplasms

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Esophageal Neoplasms

Carcinoma, Non-Small-Cell Lung

Endometrial Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Head and Neck Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Ovarian Cancer

Esophageal Cancer

Coagulants

All Drugs and Chemicals

Antineoplastic Agents

Thromboplastin

Tisotumab vedotin

Antineoplastic Agents, Immunological

All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles.

All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).

Tisotumab Vedotin

Medical Director

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

This is an open-label, multicenter trial to collect long-term safety and efficacy data and to provide ongoing access to tisotumab vedotin for patients with solid tumors who have completed a tisotumab vedotin base trial.

Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

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.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.

Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 \[RECIST 1.1\] criteria. The best overall response was reported for each participant.

The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.

The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.

Genmab

Seagen Inc.

Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.

Overall

Age, Continuous

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Clinical Trial Information

Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)

Spots Global Cancer Trial Database for Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial