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Completed

NCT Number: NCT05052723

Cabozantinib and Pembrolizumab in Metastatic Pancreas

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

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Key information

Conditions

Pancreatic Cancer Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabozantinib

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

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).

Primary outcomes

  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 outcomes

  1. Number of Participants With Response to Therapy

    Time frame: 1 year

    The proportion of participants with overall response to therapy via imaging; Overall Response Rate (%) = (Number of patients achieving Complete responses + Number of patients achieving partial responses / Total Number of patients) × 100

  2. Number of Participants With Complete Response

    Time frame: 1 year

    The proportion of participants with a complete response to therapy

  3. Number of Participants With 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

Sponsors and collaborators

Lead sponsor

Joseph Kim

Other

Collaborators

  • Exelixis
  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2021
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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