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 four 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.

- In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either:

- Pembrolizumab or,

- Pembrolizumab and carboplatin, or

- Pembrolizumab and cisplatin

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Seagen Inc.

Collaborator: Genmab

Stanford Investigator(s):

Intervention(s):

  • Drug: tisotumab vedotin
  • Drug: pembrolizumab
  • Drug: carboplatin
  • Drug: cisplatin

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Parts A, B, and C

      - 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.

      - 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 3 lines of
      systemic therapy in the metastatic setting.

         - Patients eligible for a tyrosine kinase inhibitor should have received such
         therapy. These patients should have received no more than 4 lines of
         systemic therapy 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/or a checkpoint inhibitor (CPI), if eligible, and must have
      experienced disease progression following such therapy. Participants should have
      received no more than 3 systemic lines of therapy in the recurrent or metastatic
      setting.

   - Part D

      - Participants with SCCHN must have received no previous systemic therapy in the
      recurrent or metastatic disease setting.

      - Participants with NSCLC must have histologically or cytologically documented
      squamous cell NSCLC and must have received no previous systemic therapy for
      metastatic disease or radiation therapy to the lung that is > 30 Gy within 6
      months of the first dose of study treatment.

      - PD-L1 biomarker expression as determined by a PD-L1 IHC assay should be available

      - Able to provide fresh or archival tissue for biomarker analysis

   - Baseline measurable disease as measured by RECIST v1. 1.

   - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion Criteria:

   - Participants with primary neuroendocrine or sarcomatoid histologies. For SCCHN,
   participants may not have a primary site of nasopharynx.

   - Active bleeding conditions

   - Ocular surface disease at the time of enrollment (Note: cataract is not considered
   active ocular surface disease for this protocol)

   - 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.

   - Uncontrolled tumor-related pain

   - Inflammatory lung disease. Participants with pulmonary disease are allowed if systemic
   steroids and long-term oxygen are not required

   - Peripheral neuropathy greater than or equal to Grade 2

   - Active brain metastasis

   - Part D Only: Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
   an agent directed to another stimulatory or co-inhibitory T-cell receptor.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All