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Alkylating agents

GVAX + Nivolumab + SBRT for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Daniel Laheru, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
Age >18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will test a combination of drugs and immunotherapy with radiation for pancreatic cancer patients to see if it is safe and effective.

Who is the study for?
This trial is for adults over 18 with borderline resectable pancreatic cancer, who haven't had major surgery in the last 28 days or more than one cycle of chemotherapy. They must be able to have SBRT, not be pregnant or breastfeeding, and willing to use birth control. Excluded are those with certain medical conditions, prior immunotherapy treatment, recent investigational drug/device use, other active cancers needing treatment within two years, or known infections like HIV.Check my eligibility
What is being tested?
The study tests a combination therapy for pancreatic cancer involving FOLFIRINOX (a type of chemotherapy), GVAX Pancreas Vaccine with Cyclophosphamide (to boost immune response), Nivolumab (an immunotherapy drug), and Stereotactic Body Radiation Therapy (SBRT). The goal is to assess safety and how well this multi-faceted approach works together.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's increased activity such as inflammation in various organs; typical chemo-related issues like nausea and fatigue; radiation-associated discomforts; and potential allergic responses to vaccine components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had only one month of treatment for pancreatic cancer.
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I am older than 18 years.
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I am fully active or can carry out light work.
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My organ and bone marrow functions meet the required levels.
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I am eligible for targeted radiation therapy.
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I am a woman who can have children and my pregnancy test is negative.
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My pancreatic cancer is almost operable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CD8 count (cells/mm^3) in the tumor microenvironment
Secondary outcome measures
Pathologic complete response (pCR) rate at surgical resection

Side effects data

From 2020 Phase 2 trial • 38 Patients • NCT01728779
100%
Lymphocyte Absolute Increase
100%
Fatigue
97%
Diarrhea
86%
Hyperglycemia
68%
Dyspenea
68%
Urinary Incontinence
65%
cough
59%
Nausea
59%
Anemia
59%
WBC Decrease
57%
Edema
51%
Anorexia
49%
Constipation
43%
Anxiety
41%
Depression
41%
Weight Increase
38%
Dry mouth
35%
Dyspepsia
35%
Platelet Count Decrease
32%
Headache
32%
Neuralgia
32%
Hemmorhoids
30%
Dizziness
30%
Stomach Pain
27%
Vomitting
24%
Bilirubin
24%
Weight Loss
24%
Pruritis
22%
Alopecia
19%
Bruising
19%
Concentration impairment
16%
Bloating
16%
Chills
14%
Esophogitis
11%
Hot Flashes
11%
Hyperkalemia
11%
Fecal Incontinence
11%
Dehydration
3%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)

Trial Design

1Treatment groups
Experimental Treatment
Group I: CY, Nivolumab, GVAX, and SBRTExperimental Treatment4 Interventions
CY, Nivolumab, GVAX, and SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Nivolumab
2014
Completed Phase 3
~4750
Stereotactic Body Radiation (SBRT)
2018
Completed Phase 2
~70
GVAX Pancreas Vaccine
2018
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,872 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,486 Total Patients Enrolled
Daniel Laheru, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
3 Previous Clinical Trials
151 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03161379 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the previous research on Stereotactic Body Radiation (SBRT)?

"Currently, there are 1572 ongoing clinical trials studying the effects of Stereotactic Body Radiation (SBRT). Of those active studies, 237 have reached Phase 3. Even though a large number of these trials originate in Philadelphia, Pennsylvania, there are 67454 different locations researching this treatment."

Answered by AI

What is the upper limit for subjects in this clinical trial?

"Unfortunately, this study is no longer looking for patients that meet the given criteria. However, there are 726 other trials actively recruiting cancer of pancreas patients and 1572 Stereotactic Body Radiation (SBRT) trials with open recruitment at the moment."

Answered by AI

Is Stereotactic Body Radiation (SBRT) a safe medical procedure?

"While there is some evidence suggest that Stereotactic Body Radiation (SBRT) is safe, it scores a 2 because there is no data supporting its efficacy."

Answered by AI

Can new patients still join this clinical trial?

"Unfortunately, this particular trial is no longer admitting patients. The listing was created on February 2nd, 2018 and last edited March 3rd, 2022. For individuals interested in other studies, 726 active clinical trials are currently recruiting cancer patients of the pancreas while 1572 SBRT studies are also open for enrollment."

Answered by AI

What is the primary purpose of Stereotactic Body Radiation (SBRT)?

"SBRT is a type of radiation therapy that is used to treat multiple sclerosis, as well as other conditions like leukemia, myelocytic, acute, malignant neoplasms, and unresectable melanoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
2018. "GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03161379.
~4 spots leftby Apr 2025
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