A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma

Phase 2 GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer



Sponsors


Source

Sidney Kimmel Comprehensive Cancer Center

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief Summary

The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along
with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab
combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.

Overall Status

Not yet recruiting

Start Date

2017-11-01

Completion Date

2019-09-01

Primary Completion Date

2019-09-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Pathologic complete response (pCR) rate at surgical resection.
4 years

Secondary Outcome

Measure

Time Frame

Number of subjects who receive an R0 surgical resection.
4 years
Objective response rate (ORR)
4 years
Overall survival (OS)
4 years
Distant metastasis free survival (DMFS)
4 years
Number of drug related adverse events
4 years

Enrollment

50

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.

Arm Group Label

CY, Nivolumab, GVAX, and SBRT

Other Name

CY


Intervention Type

Drug

Intervention Name


Description

Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.

Arm Group Label

CY, Nivolumab, GVAX, and SBRT

Other Name

OPDIVO


Intervention Type

Drug

Intervention Name


Description

Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.

Arm Group Label

CY, Nivolumab, GVAX, and SBRT

Other Name

PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine


Intervention Type

Radiation

Intervention Name


Description

SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).

Arm Group Label

CY, Nivolumab, GVAX, and SBRT



Eligibility

Criteria

Inclusion Criteria:

1. Have histologically proven pancreatic cancer that is borderline resectable

2. No systemic therapy for pancreatic cancer

3. Age >18 years old.

4. ECOG performance status 0-1.

5. Patients must have adequate organ and marrow function defined by study-specified
laboratory tests.

6. Woman of child bearing potential must have a negative pregnancy test.

7. Must use an acceptable form of birth control while on study.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Had major surgery within the last 28 days

2. Had an investigational drug or device within the past 28 days

3. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CTLA4, etc)

4. Prior treatment for pancreas cancer.

5. Patient on an immunosuppressive systemic treatments, such as steroids, in the past 2
years.

6. Other cancer diagnosis requiring treatment within two years

7. History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide,
GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin),
yeast or any other component of the GVAX vaccine) in this study.

8. Patients receiving growth factors within the last 14 days.

9. Currently have or have history of certain study-specified heart, liver, kidney, lung,
neurological, psychological, immune or other medical conditions.

10. Pregnant or breastfeeding.

11. Have known history of infection with HIV, hepatitis B, or hepatitis C.

12. Unwilling or unable to follow the study schedule for any reason.

Gender

All

Minimum Age

18 Years

Maximum Age

100 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Nilofer Azad, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center

Overall Contact

Last Name

Beth Onners, MSN,RN

Phone

(410) 502-2800

Email



Verification Date

2017-10-01

Lastchanged Date

2017-10-19

Firstreceived Date

2017-05-18

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

IRB00130075

Number Of Arms

1

Intervention Browse

Mesh Term

Vaccines

Cyclophosphamide

Antibodies, Monoclonal

Nivolumab

Pancrelipase

Pancreatin



Arm Group

Arm Group Label

CY, Nivolumab, GVAX, and SBRT

Arm Group Type

Experimental


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Mark Yarchoan, MD

Phone

410-955-8893

Email



Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

None (Open Label)

Masking Description

Open Label


Study First Submitted

May 18, 2017

Study First Submitted Qc

May 18, 2017

Study First Posted

May 19, 2017

Last Update Submitted

October 19, 2017

Last Update Submitted Qc

October 19, 2017

Last Update Posted

October 23, 2017


ClinicalTrials.gov processed this data on October 23, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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