Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Seagen Inc.

Collaborator: Genmab

Stanford Investigator(s):

Intervention(s):

  • Drug: tisotumab vedotin

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All