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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 : November 26, 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

February 8, 2018
February 19, 2018
November 26, 2018
June 12, 2018
December 2019   (Final data collection date for primary outcome measure)
confirmed objective response rate [ Time Frame: up to 2 years ]
Objective response based upon RECIST v1.1, assessed by independent review committee (IRC).
Same as current
Complete list of historical versions of study NCT03438396 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Trial of Tisotumab Vedotin in Cervical Cancer
A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer
A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cervical Cancer
Drug: tisotumab vedotin
All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity
Experimental: Single arm
tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W)
Intervention: Drug: tisotumab vedotin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
April 2023
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: cervical cancer
18 Years and older   (Adult, Older Adult)
No
Contact: Genmab A/S Trial Information +4570202728 clinicaltrials@genmab.com
Belgium,   Czechia,   Denmark,   Italy,   Spain,   Sweden,   United States
 
 
NCT03438396
GCT1015-04
innovaTV 204 ( Other Identifier: Genmab )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Genmab
Genmab
  • Seattle Genetics, Inc.
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Belgian Gynaecological Oncology Group
  • Gynecologic Oncology Group
Not Provided
Genmab
November 2018

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