Cabozantinib and Pembrolizumab in Metastatic Pancreas

Sponsor
Joseph Kim (Other)
Overall Status
Recruiting
CT.gov ID
NCT05052723
Collaborator
Exelixis (Industry), Merck Sharp & Dohme LLC (Industry)
21
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1
137.9
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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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 4, 2022
Anticipated Primary Completion Date :
Jul 1, 2033
Anticipated Study Completion Date :
Jul 1, 2033

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Complete response [1 year]

    The proportion of participants with a complete response to therapy

  3. Partial response [1 year]

    The proportion of participants with a partial response to therapy

  4. Overall participant survival rate [1 year]

    Overall survival rate participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Joseph Kim, Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT05052723
Other Study ID Numbers:
  • MCC-21-GI-117
First Posted:
Sep 22, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Professor, University of Kentucky
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022