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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (innovaTV 207)

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ClinicalTrials.gov Identifier: NCT03485209
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
Seagen Inc.

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE April 2, 2018
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE June 25, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
Confirmed Objective Response Rate (ORR) [ Time Frame: Through 1 month following last dose ]
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Incidence of Adverse Events [ Time Frame: Through 1 month following last dose ]
    Type, severity, and relatedness of adverse events
  • Confirmed and Unconfirmed ORR [ Time Frame: Through 1 month following last dose ]
    Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator
  • Disease Control Rate (DCR) [ Time Frame: Through 1 month following last dose ]
    Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator, or meet the SD criteria at least once after start of study treatment
  • Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]
    Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first
  • Time to Response (TTR) [ Time Frame: Through 1 month following last dose ]
    Time from the start of study treatment to the first documentation of objective response
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 2 years ]
    Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first
  • Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
    Time from the start of study treatment to date of death due to any cause
  • Cmax [ Time Frame: Through 8 days after dosing ]
    Maximum observed plasma concentration
  • Ctrough [ Time Frame: Through 8 days after dosing ]
    Observed plasma concentration at the end of the dosing interval
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 Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
Official Title  ICMJE Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Brief Summary This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are two parts to this study. In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
Detailed Description The primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with single agent tisotumab vedotin. Patients who meet eligibility criteria will be enrolled into cohorts based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous non-small cell lung cancer (NSCLC), exocrine pancreatic adenocarcinoma, and squamous cell carcinoma of the head and neck (SCCHN).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Exocrine Pancreatic Cancer
  • Carcinoma, Squamous Cell of Head and Neck
Intervention  ICMJE Drug: tisotumab vedotin
Intravenous (IV) infusion
Study Arms  ICMJE
  • Experimental: Tisotumab Vedotin - Q3W Regimen
    Tisotumab Vedotin [2.0 mg/kg] every 3 weeks
    Intervention: Drug: tisotumab vedotin
  • Experimental: Tisotumab Vedotin - 3Q4W Regimen
    Tisotumab Vedotin [0.9 mg/kg or 1.2 mg/kg] on Days 1, 8, and 15 of 28-day cycle
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2019)
250
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2018)
200
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, squamous NSCLC, or SCCHN patients who are not candidates for standard therapy.
  • All patients must have experienced disease progression on or after their most recent systemic therapy.
  • Baseline measurable disease as measured by RECIST v1. 1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Colorectal cancer patients must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecan, and/or bevacizumab. Patients should have received no more than 3 systemic regimens in the metastatic setting.
  • Patients with NSCLC must have predominant squamous histology. Patients must have received prior therapy with a platinum-based treatment and a checkpoint inhibitor (CPI), if eligible. Patients should have received no more than 2 systemic regimens in the metastatic setting.

    • Patients eligible for a tyrosine kinase inhibitor should have received such therapy. These patients should have received no more than 3 systemic regimens in the metastatic setting.
  • Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
  • Patients with SCCHN must have received prior therapy with a platinum-based regimen and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 3 systemic regimens in the recurrent/metastatic setting.

Exclusion Criteria:

  • Active bleeding conditions
  • Ocular surface disease at the time of enrollment (Note: cataract is not considered active ocular surface disease for this protocol)
  • Pulmonary disease requiring chronic medical therapy, unrelated to underlying cancer
  • Uncontrolled tumor-related pain
  • Peripheral neuropathy greater than or equal to Grade 2
  • History of another malignancy within 3 years of the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
  • Active or previous brain metastasis
  • Patients who are breastfeeding, pregnant, or planning to become pregnant from the time of informed consent until 6 months after the final study dose is administered
  • For patients with SCCHN or NSCLC, ongoing anticoagulant therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seagen Trial Information Support 8663337436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03485209
Other Study ID Numbers  ICMJE SGNTV-001
2017-005076-26 ( EudraCT Number )
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 Not Provided
Responsible Party Seagen Inc.
Study Sponsor  ICMJE Seagen Inc.
Collaborators  ICMJE Genmab
Investigators  ICMJE
Study Director: Shweta Jain, MD Seagen Inc.
PRS Account Seagen Inc.
Verification Date January 2021

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