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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485209
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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.

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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 : June 30, 2021
Estimated Study Completion Date : May 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Tisotumab Vedotin - Q3W Regimen
Tisotumab Vedotin [2.0 mg/kg] every 3 weeks
 Drug: tisotumab vedotin
Intravenous (IV) infusion
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
 Drug: tisotumab vedotin
Intravenous (IV) infusion


Outcome Measures
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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


Eligibility Criteria
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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, 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
Contacts and Locations
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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
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Contact: Seagen Trial Information Support 8663337436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Genmab
Investigators
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Study Director: Shweta Jain, MD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT03485209    
Other Study ID Numbers: SGNTV-001
2017-005076-26 ( EudraCT Number )
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Colorectal cancer
NSCLC
SCCHN
CRC
 Pancreatic cancer
Head and neck cancer
Seattle Genetics
Additional relevant MeSH terms:
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Carcinoma
Pancreatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
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
Head and Neck Neoplasms