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

• ClinicalTrials.gov Identifier: NCT03485209
• Recruitment Status: Recruiting
• First Posted: April 2, 2018
• Last Update Posted: September 8, 2021
• Sponsor: Seagen Inc.
• Collaborator: Genmab
• Information provided by (Responsible Party): Seagen Inc.

Tracking Information

• First Submitted Date: March 8, 2018
• First Posted Date: April 2, 2018
• Last Update Posted Date: September 8, 2021
• Actual Study Start Date: June 25, 2018
• Estimated Primary Completion Date: May 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 5, 2021)

Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]

Proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator

Original Primary Outcome Measures (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

Current Secondary Outcome Measures (submitted: March 5, 2021)

• Incidence of Adverse Events [ Time Frame: Up to approximately 3 years ]
  Type, severity, and relatedness of adverse events. An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
• Confirmed and Unconfirmed ORR [ Time Frame: Up to approximately 3 years ]
  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: Up to approximately 3 years ]
  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 3 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: Up to approximately 3 years ]
  Time from the start of study treatment to the first documentation of objective response
• Progression-free survival (PFS) [ Time Frame: Up to approximately 3 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 4 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
• Incidence of ATAs [ Time Frame: Through 8 days after dosing ]

Original Secondary Outcome Measures (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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
• Official Title: 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 three 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. In Part C, participants may receive tisotumab vedotin on Days 1 and 15 or Days 1, 8, and 15 on a 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Colorectal Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Exocrine Pancreatic Cancer
• Carcinoma, Squamous Cell of Head and Neck

Intervention

Drug: tisotumab vedotin

Given into the vein (IV; intravenously)

Study Arms

• Experimental: Tisotumab Vedotin - Q3W Schedule
  Tisotumab Vedotin every 3 weeks
  Intervention: Drug: tisotumab vedotin
• Experimental: Tisotumab Vedotin - 3Q4W Schedule
  Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle
  Intervention: Drug: tisotumab vedotin
• Experimental: Tisotumab Vedotin - 3Q4W/2Q4W Schedule
  Tisotumab Vedotin on Days 1, 8, and 15 of a 28-day cycle and Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle
  Intervention: Drug: tisotumab vedotin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 5, 2021): 392
• Original Estimated Enrollment (submitted: March 26, 2018): 200
• Estimated Study Completion Date: April 30, 2024
• Estimated Primary Completion Date: May 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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 brain metastasis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Canada, France, Germany, Italy, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03485209
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Seagen Inc.
• Study Sponsor: Seagen Inc.
• Collaborators: Genmab

Investigators

• Study Director: Francisco Beca, MD, PhD; Seagen Inc.

• PRS Account: Seagen Inc.
• Verification Date: September 2021