Cabozantinib and Pembrolizumab in Metastatic Pancreas

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Cabozantinib; Drug: Pembrolizumab

• Registration Number: NCT05052723
• Lead Sponsor: Joseph Kim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-22
• Study Start: 2022-01-04
• Status Verified: 2024-01
• Primary Completion: 2024-11-05
• Study Completion: 2024-11-05
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabozantinib and pembrolizumab	Cabozantinib	-
Cabozantinib and pembrolizumab	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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.

Secondary Outcome Measures

Name	Time	Method
Complete response	1 year	The proportion of participants with a complete response to therapy
Partial response	1 year	The proportion of participants with a partial response to therapy
Change in overall response to therapy	2 months, 4 months, 6 months, 9 months, 12 months	The proportion of participants with overall response to therapy via imaging
Overall participant survival rate	1 year	Overall survival rate participants

Trial Locations

Locations (1)

University of Kentucky Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States