Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (innovaTV 207)
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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 : February 2, 2021
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Sponsor:
Seagen Inc.
Collaborator:
Genmab
Information provided by (Responsible Party):
Seagen Inc.
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE | Drug: tisotumab vedotin
Intravenous (IV) infusion
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
250 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Seagen Inc. | ||||
Study Sponsor ICMJE | Seagen Inc. | ||||
Collaborators ICMJE | Genmab | ||||
Investigators ICMJE |
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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 |