NCT03245736

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 4, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

August 8, 2017

Results QC Date

October 6, 2021

Last Update Submit

October 6, 2021

Conditions

Ovary CancerCervix CancerEndometrium CancerBladder CancerProstate CancerEsophagus CancerLung Cancer, Nonsmall CellSquamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

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

    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.

    Day 1 to Week 24 plus 30 days

Secondary Outcomes (3)

  • Objective Response Rate

    Day 1 to Week 24 plus 30 days

  • Number of Participants With Increased Cancer Antigen (CA 125) Levels

    Day 1 to Week 24 plus 30 days

  • Number of Participants With Increased Prostate Specific Antigen (PSA)

    Day 1 to Week 24 plus 30 days

Study Arms (1)

Tisotumab Vedotin

EXPERIMENTAL

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

Drug: Tisotumab Vedotin

Interventions

Tisotumab VedotinDRUG

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

Also known as: TIVDAK
Tisotumab Vedotin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have either:
  • completed the base trial and have shown a clinical benefit of 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 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.
  • Acceptable renal function
  • Acceptable liver function
  • Acceptable hematological status
  • 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.
  • Male patients must be willing to use a latex condom during any sexual contact with females of childbearing potential during and for six months after the last infusion of tisotumab vedotin, even after having undergone a successful vasectomy.
  • In order to be considered as sterilized or infertile, a patient must have undergone surgical sterilization (vasectomy/bilateral tubectomy; hysterectomy and bilateral ovariectomy) or be postmenopausal (12 months or more with no period prior to enrolment).
  • 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
  • +2 more criteria

You may not qualify if:

  • Presence of CTCAE (Common Terminology 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Brian Slomovitz

Miami, Florida, 33136, United States

Location

Johann de Bono

Chelsea, SM2 5PT, United Kingdom

Location

Beatson Cancer Centre

Glasgow, United Kingdom

Location

Fiona Thistlethwaite

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Ovarian NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsUrinary Bladder NeoplasmsProstatic NeoplasmsEsophageal NeoplasmsCarcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of Head and Neck

Interventions

tisotumab vedotin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Clinical Trial Information
Organization
Genmab A/S
clinicaltrials@genmab.com
70202728

Study Officials

  • Medical Director

    Genmab

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 10, 2017

Study Start

August 23, 2017

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

November 4, 2021

Results First Posted

November 4, 2021

Record last verified: 2021-10

Locations

US(1)GB(3)