Clinical Trials /

Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

NCT03485209

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Pancreatic Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: SGNTV-001
  • SECONDARY ID: 2017-005076-26
  • NCT ID: NCT03485209

Conditions

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

Interventions

DrugSynonymsArms
tisotumab vedotinTisotumab Vedotin

Purpose

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.

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).
    

Trial Arms

NameTypeDescriptionInterventions
Tisotumab VedotinExperimentalTisotumab Vedotin [2.0 mg/kg] every 3 weeks
  • tisotumab vedotin

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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Confirmed Objective Response Rate (ORR)
Time Frame:Through 1 month following last dose
Safety Issue:
Description:Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator

Secondary Outcome Measures

Measure:Incidence of Adverse Events
Time Frame:Through 1 month following last dose
Safety Issue:
Description:Type, severity, and relatedness of adverse events
Measure:Confirmed and Unconfirmed ORR
Time Frame:Through 1 month following last dose
Safety Issue:
Description:Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator
Measure:Disease Control Rate (DCR)
Time Frame:Through 1 month following last dose
Safety Issue:
Description: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
Measure:Duration of Response (DOR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first
Measure:Time to Response (TTR)
Time Frame:Through 1 month following last dose
Safety Issue:
Description:Time from the start of study treatment to the first documentation of objective response
Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first
Measure:Overall Survival (OS)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Time from the start of study treatment to date of death due to any cause
Measure:Cmax
Time Frame:Through 8 days after dosing
Safety Issue:
Description:Maximum observed plasma concentration
Measure:Ctrough
Time Frame:Through 8 days after dosing
Safety Issue:
Description:Observed plasma concentration at the end of the dosing interval

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • Colorectal cancer
  • NSCLC
  • SCCHN
  • CRC
  • Pancreatic cancer
  • Head and neck cancer

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