Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by May Cho (ucdavis)Edward Kim (ucdavis)Jonathan W Riess (ucdavis)

Description

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 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

Official Title

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

Details

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 or tisotumab vedotin in combination with other agents. 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).

Keywords

Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Exocrine Pancreatic Cancer Carcinoma, Squamous Cell of Head and Neck Colorectal cancer NSCLC SCCHN CRC Pancreatic cancer Head and neck cancer Seattle Genetics HNSCC Carcinoma Pancreatic Neoplasms Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Carboplatin Pembrolizumab Tisotumab vedotin cisplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Davis accepting new patients
    Sacramento California 95817 United States
  • Stanford Cancer Center / Blood and Marrow Transplant Program accepting new patients
    San Jose California 95124 United States

Lead Scientists at University of California Health

  • May Cho (ucdavis)
    Assistant Professor, Hematology and Oncology. Authored (or co-authored) 8 research publications
  • Edward Kim (ucdavis)
    Associate Professor, Hematology and Oncology. Authored (or co-authored) 32 research publications
  • Jonathan W Riess (ucdavis)
    Associate Professor, Hematology and Oncology. Authored (or co-authored) 77 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT03485209
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 532 study participants
Last Updated