Cabozantinib and Pembrolizumab in Metastatic Pancreas
Study Details
Study Description
Brief Summary
This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cabozantinib and pembrolizumab
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Drug: Cabozantinib
Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
Drug: Pembrolizumab
Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
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Outcome Measures
Primary Outcome Measures
- Progression-free survival [1 year]
Progress-free survival in participants, defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever comes first.
Secondary Outcome Measures
- Change in overall response to therapy [2 months, 4 months, 6 months, 9 months, 12 months]
The proportion of participants with overall response to therapy via imaging
- Complete response [1 year]
The proportion of participants with a complete response to therapy
- Partial response [1 year]
The proportion of participants with a partial response to therapy
- Overall participant survival rate [1 year]
Overall survival rate participants
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of pancreatic ductal adenocarcinoma
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Evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies
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Patients must have adequate organ function
Exclusion Criteria:
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Chemotherapy or other locoregional anti-tumoral therapies performed within 28 days of study treatment initiation
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Received palliative radiation therapy within 2 weeks or any other radiation therapy within 4 weeks of start of study intervention
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Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
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Has a diagnosis of immunodeficiency (autoimmune disease) or is receiving chronic systemic steroid therapy
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Clinically significant cardiovascular disease
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Uncontrolled hypertension
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Inability to swallow tablets
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Kentucky Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Joseph Kim
- Exelixis
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Josepoh Kim, MD, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-21-GI-117