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Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cyclophosphamide

GVAX Pancreatic Cancer Vaccine

Pembrolizumab

SBRT

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring vaccine, immunotherapy, antibody, PD-1, radiation

Eligibility Criteria

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

Inclusion Criteria:

locally advanced pancreatic adenocarcinoma
Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment.
Age >18 years
No metastatic disease
ECOG Performance Status of 0 to 1
Adequate organ function as defined by study-specified laboratory tests
Patients must be able to have fiducials placed for SBRT
Must use acceptable form of birth control through the study
Signed informed consent form
Willing and able to comply with study procedures

Exclusion Criteria:

Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days
Patients who have had more than one line of chemotherapy
Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug
Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration
Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin.
Patients who have known history of infection with HIV, hepatitis B, or hepatitis C
Patients with evidence of interstitial lung disease
Patients on home oxygen
Patients with oxygen saturation of <92% on room air by pulse oximetry
Pregnant or lactating
Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Sites / Locations

The Sidney Kimmel Comprehensive Cancer at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

Arm Description

Outcomes

Primary Outcome Measures

Distant Metastasis Free Survival (DMFS)

DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.

Secondary Outcome Measures

Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.

Full Information

NCT ID

NCT02648282

First Posted

January 5, 2016

Last Updated

February 1, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02648282

Brief Title

Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer

Official Title

A Phase II Study of GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine in Combination With PD-1 Blockade Antibody (Pembrolizumab) and Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Locally Advanced Adenocarcinoma of the Pancreas

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

July 18, 2016 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer.

6. Conditions and Keywords

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

Pancreatic Cancer

Keywords

vaccine, immunotherapy, antibody, PD-1, radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cytoxan, CY

Intervention Description

200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses.

Intervention Type

Drug

Intervention Name(s)

GVAX Pancreatic Cancer Vaccine

Other Intervention Name(s)

Pancreas cancer vaccine, Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo

Intervention Description

2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of 8 doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses.

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

MK-3475, KEYTRUDA

Intervention Description

200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses.

Intervention Type

Radiation

Intervention Name(s)

SBRT

Other Intervention Name(s)

Stereotactic Body Radiation Therapy

Intervention Description

Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).

Primary Outcome Measure Information:

Title

Distant Metastasis Free Survival (DMFS)

Description

DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.

Time Frame

62 months

Secondary Outcome Measure Information:

Title

Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities

Description

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.

Time Frame

41 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Locally advanced pancreatic adenocarcinoma Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment. Age >18 years No metastatic disease ECOG Performance Status of 0 to 1 Adequate organ function as defined by study-specified laboratory tests Patients must be able to have fiducials placed for SBRT Must use acceptable form of birth control through the study Signed informed consent form Willing and able to comply with study procedures Exclusion Criteria: Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days Patients who have had more than one line of chemotherapy Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C Patients with evidence of interstitial lung disease Patients on home oxygen Patients with oxygen saturation of <92% on room air by pulse oximetry Pregnant or lactating Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lei Zheng, MD, PhD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Sidney Kimmel Comprehensive Cancer at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer

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