Cabozantinib and Pembrolizumab in Metastatic Pancreas

NCT ID: NCT05052723

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2024-11-05

Brief Summary

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

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabozantinib and pembrolizumab

Group Type: EXPERIMENTAL

Cabozantinib

Intervention Type: DRUG

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.

Pembrolizumab

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exelixis

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Joseph Kim

OTHER

Sponsor Role: lead

Responsible Party

Joseph Kim

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Josepoh Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Countries

United States

References

McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

Reference Type: DERIVED

PMID: 36410913 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MCC-21-GI-117

Identifier Type: -

Identifier Source: org_study_id