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Cabozantinib and Pembrolizumab in Metastatic Pancreas

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cabozantinib

Pembrolizumab

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Adenocarcinoma, Metastatic

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kentucky Markey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cabozantinib and pembrolizumab

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in overall response to therapy

The proportion of participants with overall response to therapy via imaging

Complete response

The proportion of participants with a complete response to therapy

Partial response

The proportion of participants with a partial response to therapy

Overall participant survival rate

Overall survival rate participants

Full Information

NCT ID

NCT05052723

First Posted

September 12, 2021

Last Updated

March 8, 2023

Sponsor

Joseph Kim

Collaborators

Exelixis, Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05052723

Brief Title

Cabozantinib and Pembrolizumab in Metastatic Pancreas

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 4, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

July 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Joseph Kim

Collaborators

Exelixis, Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Adenocarcinoma, Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cabozantinib and pembrolizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cabozantinib

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Intervention Description

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).

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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 Outcome Measure Information:

Title

Change in overall response to therapy

Description

The proportion of participants with overall response to therapy via imaging

Time Frame

2 months, 4 months, 6 months, 9 months, 12 months

Title

Complete response

Description

The proportion of participants with a complete response to therapy

Time Frame

1 year

Title

Partial response

Description

The proportion of participants with a partial response to therapy

Time Frame

1 year

Title

Overall participant survival rate

Description

Overall survival rate participants

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joseph Kim, MD

Phone

859-257-4490

joseph.kim@uky.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josepoh Kim, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Kim, MD

Phone

859-257-4490

joseph.kim@uky.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cabozantinib and Pembrolizumab in Metastatic Pancreas

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