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A Trial of Tisotumab Vedotin in Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438396
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : May 24, 2019
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

Tracking Information
First Submitted Date  ICMJE February 8, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE June 12, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
confirmed objective response rate [ Time Frame: up to 2 years ]
Objective response based upon RECIST v1.1, assessed by independent review committee (IRC).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • Duration of response [ Time Frame: up to 2 years ]
    Duration of response (DOR) based upon RECIST v1.1
  • Progression free survival [ Time Frame: up to 2 years ]
    Progression free survival based upon RECIST v1.1
  • Overall survival [ Time Frame: up to 2 years ]
    Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Tisotumab Vedotin in Cervical Cancer
Official Title  ICMJE A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer
Brief Summary A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE Drug: tisotumab vedotin
All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity
Study Arms  ICMJE Experimental: Single arm
tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W)
Intervention: Drug: tisotumab vedotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)
102
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2018)
100
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: cervical cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   Denmark,   Italy,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438396
Other Study ID Numbers  ICMJE GCT1015-04
innovaTV 204 ( Other Identifier: Genmab )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Genmab
Study Sponsor  ICMJE Genmab
Collaborators  ICMJE
  • Seattle Genetics, Inc.
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Belgian Gynaecological Oncology Group
  • Gynecologic Oncology Group
Investigators  ICMJE Not Provided
PRS Account Genmab
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP