Cabozantinib and Pembrolizumab in Metastatic Pancreas

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05052723
• Other study ID #: MCC-21-GI-117
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 4, 2022
• Est. completion date: December 19, 2024

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 19, 2024
• Est. primary completion date: December 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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.
• 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).

Locations

Country	Name	City	State
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Joseph Kim	Exelixis, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in overall response to therapy	The proportion of participants with overall response to therapy via imaging	2 months, 4 months, 6 months, 9 months, 12 months
Secondary	Complete response	The proportion of participants with a complete response to therapy	1 year
Secondary	Partial response	The proportion of participants with a partial response to therapy	1 year
Secondary	Overall participant survival rate	Overall survival rate participants	1 year