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Recruiting
I'm InterestedTrial ID: NCT03485209,9,18,30,55,56,62,80,48551,45550,48550
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Professor of Medicine (Oncology)
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.
drug: tisotumab vedotin
drug: pembrolizumab
drug: carboplatin
drug: cisplatin
Recruiting
I'm Interested
Stanford Cancer Center South Bay
2589 Samaritan Drive
San Jose,
CA
95124
Sabrina Biedermann
(650) 498-6000