Cabozantinib and Pembrolizumab in Metastatic Pancreas

Study Overview
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Brief Summary
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This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.

Official Title
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Phase II Clinical Trial Evaluating Cabozantinib and Pembrolizumab in Metastatic Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Cabozantinib
* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of pancreatic ductal adenocarcinoma Evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies Patients must have adequate organ function Exclusion Criteria: Chemotherapy or other locoregional anti-tumoral therapies performed within 28 days of study treatment initiation Received palliative radiation therapy within 2 weeks or any other radiation therapy within 4 weeks of start of study intervention Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation Has a diagnosis of immunodeficiency (autoimmune disease) or is receiving chronic systemic steroid therapy Clinically significant cardiovascular disease Uncontrolled hypertension Inability to swallow tablets

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cabozantinib and pembrolizumab<br> | Drug: Cabozantinib<br>* 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.<br>Drug: Pembrolizumab<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall response to therapy | The proportion of participants with overall response to therapy via imaging | 2 months, 4 months, 6 months, 9 months, 12 months | 
| Complete response | The proportion of participants with a complete response to therapy | 1 year | 
| Partial response | The proportion of participants with a partial response to therapy | 1 year | 
| Overall participant survival rate | Overall survival rate participants | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenocarcinoma, Metastatic