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

Official Title

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumours

Summary:

This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumours and what side effects (unwanted effects) may occur. The treatment will be given to patients every three weeks.

Trial Description

Primary Outcome:

  • Confirmed Objective Response Rate (ORR)
Secondary Outcome:
  • Incidence of Adverse Events
  • Confirmed and Unconfirmed ORR
  • Disease Control Rate (DCR)
  • Duration of Response (DOR)
  • Time to Response (TTR)
  • Progression-free survival (PFS)
  • Overall Survival (OS)
  • Cmax
  • Ctrough
The primary goal of this global, open label, multicentre trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumours. 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 tumour 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).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society