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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 : November 2, 2018
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
Seattle Genetics, Inc.

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. The treatment will be given to patients every three weeks.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Exocrine Pancreatic Cancer Carcinoma, Squamous Cell of Head and Neck Drug: tisotumab vedotin Phase 2

Detailed Description:
The primary goal of this global, open label, multicenter 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 every three weeks. Patients who meet eligibility criteria will be enrolled into one of 4 cohorts of tumor types known to express Tissue Factor. These 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Tisotumab Vedotin
Tisotumab Vedotin [2.0 mg/kg] every 3 weeks
Drug: tisotumab vedotin
Intravenous (IV) infusion [2.0 mg/kg] every 3 weeks




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Through 1 month following last dose ]
    Type, severity, and relatedness of adverse events

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Cmax [ Time Frame: Through 8 days after dosing ]
    Maximum observed plasma concentration

  9. Ctrough [ Time Frame: Through 8 days after dosing ]
    Observed plasma concentration at the end of the dosing interval



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, irinotecean, 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, a tyrosine kinase inhibitor, and a checkpoint inhibitor (CPI), if eligible. Patients should have received no more than 2 systemic regimens in the locally advanced or 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 2 systemic regimens in the recurrent/metastatic setting.

Exclusion Criteria:

  • Active bleeding conditions
  • Ocular surface disease at the time of enrollment
  • 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

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): NCT03485209


Contacts
Contact: Seattle Genetics Trial Information Support 8663337436 clinicaltrials@seagen.com

Locations
United States, California
University of California Davis Recruiting
Davis, California, United States, 95616
Contact: Michelle Cregan    916-734-8512    mpcregan@ucdavis.edu   
Principal Investigator: May Cho         
Stanford Cancer Center / Blood and Marrow Transplant Program Recruiting
Stanford, California, United States, 94305
Contact: Ann Moffat    669-233-2816    amoffat@stanford.edu   
Principal Investigator: Omid Tehrani         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Erica Carbone    203-737-4645    erica.carbone@yale.edu   
Principal Investigator: Jill Lacy, MD         
United States, Florida
Shands Cancer Center / University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Ashton Monismith    352-265-0680    amonismith@ufl.edu   
Principal Investigator: Thomas George, MD         
United States, Georgia
Winship Cancer Institute / Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Monique Guyinn    404-778-1900    monique.guyinn@emory.edu   
Principal Investigator: Conor Steuer         
United States, Illinois
Ingalls Cancer Care / Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Margaret Marriott    703-339-4800    mmarriott@ingalls.org   
Principal Investigator: Kimberly Kruczek, MD         
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Catherine Conway    502-629-4267    catherine.conway@nortonhealthcare.org   
Principal Investigator: John Hamm, MD         
United States, Minnesota
HealthPartners Institute Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Alissa Gavenda    952-993-6071    Alissa.Gavenda@ParkNicollet.com   
Principal Investigator: Daniel Anderson, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Zack Godwin    503-494-1617    godwinz@ohsu.edu   
Principal Investigator: Matthew Taylor, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: John Vatkevich    401-444-6217    John.vatkevich@lifespan.org   
Principal Investigator: Howard Safran         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Meiyue Hong    713-745-4367    mghong@mdanderson.org   
Principal Investigator: David Hong         
Joe Arrington Cancer Research and Treatment Center Recruiting
Lubbock, Texas, United States, 79410
Contact: Mary Jane Flores    806-725-8000    maryjane.Flores@stjoe.org   
Principal Investigator: Isaac Tafur, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Genmab
Investigators
Study Director: Shweta Jain, MD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03485209     History of Changes
Other Study ID Numbers: SGNTV-001
2017-005076-26 ( EudraCT Number )
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 31, 2018

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

Keywords provided by Seattle Genetics, Inc.:
Colorectal cancer
NSCLC
SCCHN
CRC
Pancreatic cancer
Head and neck cancer

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Squamous Cell