NCT05052723

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 19, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

September 12, 2021

Results QC Date

November 4, 2025

Last Update Submit

November 4, 2025

Conditions

Pancreatic Cancer

Keywords

AdenocarcinomaMetastatic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of Participants With Response to Therapy

    1 year

  • Number of Participants With Complete Response

    1 year

  • Number of Participants With Partial Response

    1 year

  • Overall Participant Survival Rate

    1 year

Study Arms (1)

Cabozantinib and pembrolizumab

EXPERIMENTAL
Drug: CabozantinibDrug: Pembrolizumab

Interventions

CabozantinibDRUG

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.

Cabozantinib and pembrolizumab
PembrolizumabDRUG

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).

Cabozantinib and pembrolizumab

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • 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.

    PMID: 36410913DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenocarcinomaNeoplasm Metastasis

Interventions

cabozantinibpembrolizumab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Joseph Kim
Organization
University of Kentucky
joseph.kim@uky.edu
859-257-4490

Study Officials

  • Josepoh Kim, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2021

First Posted

September 22, 2021

Study Start

January 4, 2022

Primary Completion

November 5, 2024

Study Completion

November 5, 2024

Last Updated

November 19, 2025

Results First Posted

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)