Pancreatic CancerPhase 2NCT05052723
Cabozantinib and Pembrolizumab in Metastatic Pancreas
A Phase 2 study testing Cabozantinib and Pembrolizumab in people with Pancreatic Cancer, run by Joseph Kim at 1 site in United States.
Trial summary
This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cabozantinib and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 5 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: Phase II Clinical Trial Evaluating Cabozantinib and Pembrolizumab in Metastatic Pancreatic Cancer
This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- Cabozantinib, Pembrolizumab
- Keywords
- Adenocarcinoma, Metastatic
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib and pembrolizumab | Experimental | Not described Receives: Drug: Cabozantinib; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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
Measured: 1 year
Number of Participants With Complete Response
The proportion of participants with a complete response to therapy
Measured: 1 year
Number of Participants With Partial Response
The proportion of participants with a partial response to therapy
Measured: 1 year
Overall Participant Survival Rate
Overall survival rate participants
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start4 Jan 2022
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Exelixis, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Joseph Kim, University of Kentucky
- Investigators
- Josepoh Kim, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052723
- Sponsor's protocol ID
- MCC-21-GI-117
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2021
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial Evaluating Cabozantinib and Pembrolizumab in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05052723
- Acronym / sponsor ID
- MCC-21-GI-117
- Conditions
- Pancreatic Cancer
- Keywords
- Adenocarcinoma, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Joseph KimUniversity, hospital or other
- Collaborators
- Exelixis, Merck Sharp & Dohme LLC
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Posted 19 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib and pembrolizumab | Experimental | Drug: Cabozantinib, Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibCabozantinib (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 | Cabozantinib and pembrolizumab |
| PembrolizumabPembrolizumab 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). | Drug | Cabozantinib and pembrolizumab |
Primary outcome
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.
4 secondary outcomes
Number of Participants With Response to Therapy
Time frame: 1 year
Number of Participants With Complete Response
Time frame: 1 year
Number of Participants With Partial Response
Time frame: 1 year
Overall Participant Survival Rate
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36410913McDonald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josepoh Kim, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabozantinib and Pembrolizumab in people with Pancreatic Cancer, run by Joseph Kim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.