search
Back to results

A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tislelizumab
SX-682
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Adenocarcinoma, Resectable pancreas cancer, Tislelizumab, Anti-PD-1, PD-L1, Antibody, SX-682, CXCR1/2 (chemokine receptor), CXCR1/2 inhibitor, Small molecule, Immunotherapy

Eligibility Criteria

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

Inclusion Criteria: Ability to understand and willingness to sign a written informed consent document. Age ≥18 years. Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas. Tumor must be resectable. Patient's acceptance to have a tumor biopsy. ECOG performance status 0 or 1 Patients must have adequate organ and marrow function defined by study-specified laboratory tests. For both Women and Men, must use acceptable form of birth control while on study. Exclusion Criteria: Have received any anti-pancreatic cancer therapy. Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures Subjects with active, known or suspected autoimmune disease that may relapse. Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration. Active infection requiring systemic therapy. Infection with HIV or hepatitis B or C at screening• History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements. Prior allogeneic stem cell transplantation or organ transplantation Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug. Have received a live vaccine ≤ 28 days before first dose of study drug. Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study. ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome. Severe hypersensitivity reaction to any monoclonal antibody. Concurrent participation in another therapeutic clinical study Pregnant or breastfeeding

Sites / Locations

  • Johns Hopkins SKCCCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A - Tislelizumab and SX-682

Arm Description

Outcomes

Primary Outcome Measures

Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells
The change in density of intratumoral granzyme B+ CD137+ T cells before and after neoadjuvant treatment with tislelizumab and SX-682.
Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response
The number of patients with a grade 0-2 pathologic response as defined by the College of American Pathologists (CAP) tumor regression grading system.

Secondary Outcome Measures

Number of participants experiencing grade 3 or above drug-related toxicities
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death from any cause. Patients who have not died will be censored at the last date known to be alive. Estimation based on the Kaplan-Meier curve.
Disease Free Survival (DFS)
DFS is defined as the time from the first dose of study treatment until evidence of disease recurrence or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, DFS will be censored on the date of last visit where disease progression was evaluable. Estimation based on the Kaplan-Meier curve.

Full Information

First Posted
October 28, 2022
Last Updated
October 13, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
BeiGene, Syntrix Biosystems, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05604560
Brief Title
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
Official Title
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
BeiGene, Syntrix Biosystems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and clinical activity of tadalafil, pembrolizumab, ipilimumab, and CRS-207 in subjects with metastatic pancreatic adenocarcinoma who have progressed after at least 1 prior chemotherapy regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Adenocarcinoma, Resectable pancreas cancer, Tislelizumab, Anti-PD-1, PD-L1, Antibody, SX-682, CXCR1/2 (chemokine receptor), CXCR1/2 inhibitor, Small molecule, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A - Tislelizumab and SX-682
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Patients will receive Tislelizumab (200 mg intravenous) on Day 1 of Cycles 1-6. Cycle 1 will be 14 days long and occur prior to surgery. Cycle 2 will be 14 days long and occur prior to standard of care chemotherapy. Cycles 3-6 will each be 21 days long and will be given after completion of standard of care chemotherapy.
Intervention Type
Drug
Intervention Name(s)
SX-682
Intervention Description
Patients will receive SX-682 (200 mg twice daily by mouth) on Days 1-14 of Cycles 1-2 and Days 1-21 of Cycles 3-6. Cycle 1 will be 14 days long and occur prior to surgery. Cycle 2 will be 14 days long and occur prior to standard of care chemotherapy. Cycles 3-6 will each be 21 days long and will be given after completion of standard of care chemotherapy.
Primary Outcome Measure Information:
Title
Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells
Description
The change in density of intratumoral granzyme B+ CD137+ T cells before and after neoadjuvant treatment with tislelizumab and SX-682.
Time Frame
Baseline and 2 weeks
Title
Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response
Description
The number of patients with a grade 0-2 pathologic response as defined by the College of American Pathologists (CAP) tumor regression grading system.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Number of participants experiencing grade 3 or above drug-related toxicities
Description
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
Time Frame
4 years
Title
Overall Survival (OS)
Description
OS is defined as the time from the first dose of study treatment to death from any cause. Patients who have not died will be censored at the last date known to be alive. Estimation based on the Kaplan-Meier curve.
Time Frame
4 years
Title
Disease Free Survival (DFS)
Description
DFS is defined as the time from the first dose of study treatment until evidence of disease recurrence or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, DFS will be censored on the date of last visit where disease progression was evaluable. Estimation based on the Kaplan-Meier curve.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and willingness to sign a written informed consent document. Age ≥18 years. Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas. Tumor must be resectable. Patient's acceptance to have a tumor biopsy. ECOG performance status 0 or 1 Patients must have adequate organ and marrow function defined by study-specified laboratory tests. For both Women and Men, must use acceptable form of birth control while on study. Exclusion Criteria: Have received any anti-pancreatic cancer therapy. Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures Subjects with active, known or suspected autoimmune disease that may relapse. Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration. Active infection requiring systemic therapy. Infection with HIV or hepatitis B or C at screening• History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements. Prior allogeneic stem cell transplantation or organ transplantation Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug. Have received a live vaccine ≤ 28 days before first dose of study drug. Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study. ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome. Severe hypersensitivity reaction to any monoclonal antibody. Concurrent participation in another therapeutic clinical study Pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Apostol, RN
Phone
410-614-3644
Email
GIClinicalTrials@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joann Santmyer, RN
Phone
410-614-3644
Email
GIClinicalTrials@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Christenson, MD
Organizational Affiliation
SKCCC Johns Hopkins Medical Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins SKCCC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Apostol, RN
Phone
410-614-3644
Email
GIClinicalTrials@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Joann Santmyer, RN
Phone
410-614-3644
Email
GIClinicalTrials@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Eric Christenson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer

We'll reach out to this number within 24 hrs