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CompletedNCT05052723Updated Nov 19, 2025Results posted

Cabozantinib and Pembrolizumab in Metastatic Pancreas

A Phase 2 interventional study of Cabozantinib and Pembrolizumab in Pancreatic Cancer, sponsored by Joseph Kim. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Joseph Kim · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Adenocarcinoma
  • Metastatic
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 21 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Joseph Kim is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Cabozantinib and pembrolizumab

    Drug: Cabozantinib · Drug: Pembrolizumab

Interventions

  • DrugCabozantinib

    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.

  • DrugPembrolizumab

    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).

06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. Number of Participants With Response to Therapy

    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

    Time frame: 1 year

  2. Number of Participants With Complete Response

    The proportion of participants with a complete response to therapy

    Time frame: 1 year

  3. Number of Participants With Partial Response

    The proportion of participants with a partial response to therapy

    Time frame: 1 year

  4. Overall Participant Survival Rate

    Overall survival rate participants

    Time frame: 1 year

07

Results

Posted Nov 19, 2025

Participant flow

Participant flow — Overall Study
MilestoneCabozantinib and pembrolizumab
Started21
Completed2
Not completed19
Withdrew: Death19

Outcome measures

PrimaryProgression-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.

Time frame:
1 year
Reported as:
Count of participants · Participants
Progression-free Survival
ParticipantsCabozantinib and pembrolizumab
Progression-free Survival2
SecondaryNumber of Participants With Response to Therapy

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

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Response to Therapy
ParticipantsCabozantinib and pembrolizumab
Number of Participants With Response to Therapy1
SecondaryNumber of Participants With Complete Response

The proportion of participants with a complete response to therapy

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Complete Response
ParticipantsCabozantinib and pembrolizumab
Number of Participants With Complete Response0
SecondaryNumber of Participants With Partial Response

The proportion of participants with a partial response to therapy

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Partial Response
ParticipantsCabozantinib and pembrolizumab
Number of Participants With Partial Response1
SecondaryOverall Participant Survival Rate

Overall survival rate participants

Time frame:
1 year
Reported as:
Count of participants · Participants
Overall Participant Survival Rate
ParticipantsCabozantinib and pembrolizumab
Overall Participant Survival Rate2

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cabozantinib and pembrolizumab19/21 (90.5%)13/21 (61.9%)20/21 (95.2%)
Most frequent serious events
Showing 10 of 52
Most frequent serious events
EventCabozantinib and pembrolizumab
NauseaGastrointestinal disorders3/21
Alkaline phosphatase increasedInvestigations3/21
Acute kidney injuryRenal and urinary disorders3/21
Abdominal PainGastrointestinal disorders2/21
DiarrheaGastrointestinal disorders2/21
Disease ProgressionGeneral disorders2/21
SepsisInfections and infestations2/21
Blood bilirubin increasedInvestigations2/21
DehydrationMetabolism and nutrition disorders2/21
HypokalemiaMetabolism and nutrition disorders2/21
Most frequent other events
Showing 10 of 117
Most frequent other events
EventCabozantinib and pembrolizumab
FatigueGeneral disorders14/21
Metabolism and nutrition disordersInvestigations14/21
DiarrheaGastrointestinal disorders11/21
NauseaGastrointestinal disorders11/21
HypocalcemiaInvestigations11/21
Aspartate aminotransferase increasedInvestigations10/21
AnorexiaInvestigations10/21
Alanine aminotransferase increasedInvestigations9/21
HypoalbuminemiaInvestigations8/21
HypertensionVascular disorders8/21

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cabozantinib and Pembrolizumab
Mean66 ± 7.19
Sex: Female, Male
Sex: Female, Male(Participants)Cabozantinib and Pembrolizumab
Female11
Male10
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cabozantinib and Pembrolizumab
Hispanic or Latino0
Not Hispanic or Latino20
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cabozantinib and Pembrolizumab
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White18
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Cabozantinib and Pembrolizumab
United States21
08

Study locations

1 site
  • University of Kentucky Markey Cancer Center
    Lexington, Kentucky 40536, United States
09

References and documents

Publications

  • 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. PubMed 36410913 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 27, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05052723
Lead sponsor
Joseph Kim
Collaborators
Exelixis, Merck Sharp & Dohme LLC
Responsible party
Joseph Kim (Professor, University of Kentucky) — Sponsor-investigator
First posted
Sep 22, 2021
Start date
Jan 4, 2022
Primary completion
Nov 5, 2024
Completion
Nov 5, 2024
Results posted
Nov 19, 2025
Last update
Nov 19, 2025

Study contacts

Josepoh Kim, MD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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