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Cabozantinib and Pembrolizumab in Metastatic Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05052723
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : March 2, 2022
Sponsor:
Collaborators:
Exelixis
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Joseph Kim, University of Kentucky

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Cabozantinib Drug: Pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial Evaluating Cabozantinib and Pembrolizumab in Metastatic Pancreatic Cancer
Actual Study Start Date : January 4, 2022
Estimated Primary Completion Date : July 2033
Estimated Study Completion Date : July 2033

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cabozantinib and pembrolizumab 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).




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 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 :
  1. Change in overall response to therapy [ Time Frame: 2 months, 4 months, 6 months, 9 months, 12 months ]
    The proportion of participants with overall response to therapy via imaging

  2. Complete response [ Time Frame: 1 year ]
    The proportion of participants with a complete response to therapy

  3. Partial response [ Time Frame: 1 year ]
    The proportion of participants with a partial response to therapy

  4. Overall participant survival rate [ Time Frame: 1 year ]
    Overall survival rate participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052723


Contacts
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Contact: Joseph Kim, MD 859-257-4490 joseph.kim@uky.edu

Locations
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United States, Kentucky
University of Kentucky Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Joseph Kim, MD    859-257-4490    joseph.kim@uky.edu   
Sponsors and Collaborators
Joseph Kim
Exelixis
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Josepoh Kim, MD University of Kentucky
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Responsible Party: Joseph Kim, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT05052723    
Other Study ID Numbers: MCC-21-GI-117
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joseph Kim, University of Kentucky:
Adenocarcinoma
Metastatic
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents