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A Trial of Tisotumab Vedotin in Cervical Cancer

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ClinicalTrials.gov Identifier: NCT03438396
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
Seattle Genetics, Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Belgian Gynaecological Oncology Group
Gynecologic Oncology Group
Information provided by (Responsible Party):
Genmab

Brief Summary:
A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: tisotumab vedotin Phase 2

Detailed Description:
The purpose of the trial is to evaluate the efficacy and safety/tolerability of tisotumab vedotin in patients with previously treated, recurrent or metastatic cervical cancer. Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of tumors including cervical cancer. Preliminary safety and efficacy data observed in a cohort of previously treated cervical cancer patients suggest a positive benefit risk profile for this population of high unmet need.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Single arm
tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W)
Drug: tisotumab vedotin
All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity




Primary Outcome Measures :
  1. confirmed objective response rate [ Time Frame: up to 2 years ]
    Objective response based upon RECIST v1.1, assessed by independent review committee (IRC).


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: up to 2 years ]
    Duration of response (DOR) based upon RECIST v1.1

  2. Progression free survival [ Time Frame: up to 2 years ]
    Progression free survival based upon RECIST v1.1

  3. Overall survival [ Time Frame: up to 2 years ]
    Overall survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cervical cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.
  • Measurable disease according to RECIST v1.1 as assessed by IRC.
  • Age ≥ 18 years.
  • 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 for patients of reproductive potential.
  • All patients must provide a fresh or archival biopsy during screening.
  • Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.

Exclusion Criteria

  • Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
  • Known past or current coagulation defects leading to an increased risk of bleeding;
  • Ongoing major bleeding
  • Active ocular surface disease
  • Known past or current malignancy other than the inclusion diagnosis.
  • Peripheral neuropathy grade ≥ 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438396


Contacts
Contact: Genmab A/S Trial Information +4570202728 clinicaltrials@genmab.com

  Show 57 Study Locations
Sponsors and Collaborators
Genmab
Seattle Genetics, Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Belgian Gynaecological Oncology Group
Gynecologic Oncology Group

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT03438396     History of Changes
Other Study ID Numbers: GCT1015-04
innovaTV 204 ( Other Identifier: Genmab )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female