Cabozantinib and Pembrolizumab in Metastatic Pancreas

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Cabozantinib; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky Markey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cabozantinib and pembrolizumab

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.; Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complete response	The proportion of participants with a complete response to therapy	1 year
Partial response	The proportion of participants with a partial response to therapy	1 year
Overall participant survival rate	Overall survival rate participants	1 year

Collaborators and Investigators

• Sponsor: Joseph Kim
• Collaborators: Merck Sharp & Dohme LLC; Exelixis
• Investigators: Principal Investigator: Josepoh Kim, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Estimated): December 19, 2024
• Study Completion (Estimated): December 19, 2024

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Adenocarcinoma; Metastatic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: MCC-21-GI-117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No