A Study of the Safety and Effectiveness of the Experimental Medicine Tisotumab Vedotin for Solid Tumors

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: cancer, solid tumors, colorectal cancer, squamous non-small cell lung cancer, NSCLC, pancreatic cancer, squamous cell cancer of the head and neck, SCCHN
Type: Drug study, Phase 2
Target:
20 Participants
Investigator:
Description
We are doing this study to find out if tisotumab vedotin treats solid tumor cancer. We want to see if patients with your kind of cancer respond to the drug. We want to see how long it takes patients to respond to tisotumab vedotin and how long the response lasts. We also want to learn more about any side effects patients experience during treatment with tisotumab vedotin.

Tisotumab vedotin is a type of drug called an antibody drug conjugate or ADC. ADCs usually have 2 parts.
● Antibody: Antibodies are part of your immune system. Usually, they help protect you from getting sick. In tisotumab vedotin, we are using an antibody that is designed to find and stick to the solid tumor cancer cells in your body.
● Drug: the part of the ADC that kills cells. The cell-killing part of tisotumab vedotin is a drug called MMAE.

In tisotumab vedotin, the antibody part is designed to stick to cancer cells so that the drug part can kill them. It may also stick to some non-cancer cells in your body.

We are asking patients with four types of solid tumor cancer to take part in this study. The four types are colorectal cancer, squamous non-small cell lung cancer (NSCLC), pancreatic cancer, and squamous cell cancer of the head and neck (SCCHN).

More than 200 people with cancer have already been given tisotumab vedotin in research studies. These studies tested different doses of tisotumab vedotin to see if it is safe in people. They also tested how well tisotumab vedotin works to treat cancer.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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, irinotecean, 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We will give you tisotumab vedotin in 21-day cycles. If your cancer stays the same or gets better, without any bad side effects, you can keep getting treated with tisotumab vedotin in the study. After you stop receiving tisotumab vedotin, we will ask you to have follow-up phone calls about every 12 weeks until the study is closed.
Recruitment period
From July 17, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Colorectal Neoplasms
  • Carcinoma
  • Non-Small-Cell Lung
  • Exocrine Pancreatic Cancer
  • Squamous Cell of Head and Neck