Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
Trial ID or NCT#
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 two 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.
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
- - 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.
- - 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
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