Trial Outcomes & Findings for Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors. (NCT NCT03245736)

Last Updated: 2021-11-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Day 1 to Week 24 plus 30 days

Results posted on

2021-11-04

Participant Flow

All participants entered the trial following completion of other tisotumab vedotin trials such as GEN701 and GEN702. A total of 5 participants took part in the trial at 3 sites in the United Kingdom and 1 site in the United States from 23 August 2017 to 10 January 2019.

Six participants were screened, 5 of which were enrolled.

Participant milestones

Participant milestones
Measure	Tisotumab Vedotin 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 Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Tisotumab Vedotin 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 Study Adverse Event	1
Overall Study Progressive Disease	4

Baseline Characteristics

Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tisotumab Vedotin n=5 Participants 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.
Age, Continuous	50.4 years STANDARD_DEVIATION 10.46 • n=5 Participants
Age, Customized In utero	0 Participants n=5 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	5 Participants n=5 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Week 24 plus 30 days

Outcome measures

Outcome measures
Measure	Tisotumab Vedotin n=5 Participants 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.
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)	5 Participants

SECONDARY outcome

Timeframe: Day 1 to Week 24 plus 30 days

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.

Outcome measures

Outcome measures
Measure	Tisotumab Vedotin n=5 Participants 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.
Objective Response Rate Complete Response	0 Participants
Objective Response Rate Partial Response	2 Participants
Objective Response Rate Stable Disease	2 Participants
Objective Response Rate Progressive Disease	1 Participants

SECONDARY outcome

Timeframe: Day 1 to Week 24 plus 30 days

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

Outcome measures

Outcome measures
Measure	Tisotumab Vedotin n=2 Participants 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.
Number of Participants With Increased Cancer Antigen (CA 125) Levels	1 Participants

SECONDARY outcome

Timeframe: Day 1 to Week 24 plus 30 days

Population: No participants with prostate cancer participated in this trial.

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

Outcome measures

Outcome data not reported

Adverse Events

Overall

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall n=5 participants at risk 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.
Nervous system disorders Peripheral sensorimotor neuropathy	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days

Other adverse events

Other adverse events
Measure	Overall n=5 participants at risk 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.
Nervous system disorders Neuropathy peripheral	80.0% 4/5 • Number of events 5 • Day 1 to Week 24 plus 30 days
Nervous system disorders Balance disorder	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	40.0% 2/5 • Number of events 2 • Day 1 to Week 24 plus 30 days
Metabolism and nutrition disorders Decreased appetite	40.0% 2/5 • Number of events 2 • Day 1 to Week 24 plus 30 days
Eye disorders Retinal exudates	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Number of events 2 • Day 1 to Week 24 plus 30 days
Infections and infestations Localised infection	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
General disorders Fatigue	20.0% 1/5 • Number of events 3 • Day 1 to Week 24 plus 30 days
Eye disorders Ocular toxicity	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Eye disorders Corneal thinning	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Infections and infestations Upper respiratory tract infection	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Eye disorders Punctate keratitis	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Blood and lymphatic system disorders Lymphopenia	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Vascular disorders Venous thrombosis limb	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days
Vascular disorders Thrombophlebitis superficial	20.0% 1/5 • Number of events 1 • Day 1 to Week 24 plus 30 days

Additional Information

Clinical Trial Information

Genmab A/S

Phone: 70202728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All proposed publications and presentations shall be submitted to the sponsor for its review at least 30 days before such presentation or publication is submitted to any third party.
Publication restrictions are in place

Restriction type: OTHER