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 : December 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Exocrine Pancreatic Cancer Carcinoma, Squamous Cell of Head and Neck | Drug: tisotumab vedotin | Phase 2 |
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 |

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 |
- 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
- 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

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

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
Contact: Seagen Trial Information Support | 8663337436 | clinicaltrials@seagen.com |

Study Director: | Shweta Jain, MD | Seagen Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal cancer NSCLC SCCHN CRC |
Pancreatic cancer Head and neck cancer Seattle Genetics |
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 |