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Cancer Vaccine

Immunotherapy for Pancreatic Cancer

Phase 2
Recruiting
Led By Lei Zheng, MD, PhD
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
ECOG Performance Status of 0 to 1
Newly diagnosed or clinically-suspected adenocarcinoma of the head, neck, or uncinate process of the pancreas
Must not have
Received any type of anti-cancer treatment or immunotherapy for pancreas cancer
Evidence of active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Summary

This trial will test different combinations of immunotherapy drugs given before and after surgery in patients with pancreatic cancer that can be removed by surgery.

Who is the study for?
This trial is for people with a type of pancreatic cancer that can be surgically removed. Participants should be in good physical condition (ECOG 0-1), have proper organ function, and not have had any prior cancer treatments or immunotherapies for their pancreatic cancer. They must also agree to use birth control.Check my eligibility
What is being tested?
The study tests different combinations of immunotherapy drugs before and after surgery in patients with resectable pancreatic ductal adenocarcinoma. Drugs tested include Cyclophosphamide, GVAX, Urelumab, BMS-986253, and Nivolumab.See study design
What are the potential side effects?
Possible side effects may include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, potential liver issues from the medications used in the therapy combinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my daily activities without help.
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I have been diagnosed with a specific type of cancer in my head, neck, or pancreas.
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My tumor can be removed with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received treatment for pancreatic cancer.
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I currently have an active infection.
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I have a history of HIV, hepatitis B, or hepatitis C.

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
IL17A expression
Intratumoral CD8+CD137+cells
Intratumoral granzyme B+PD-1+CD137+ cells
+1 more
Secondary outcome measures
Disease Free Survival
Drug-Related Adverse Events
Overall Survival

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D: BMS-986253 and NivolumabExperimental Treatment2 Interventions
Patients receive BMS-986253 and nivolumab on day 0 (Cycle 1), 15 days prior to surgery. 6-10 weeks after surgery, patients receive Cycle 2, with nivolumab on day 0 and BMS-986253 on days 0 and 14. Patients then receive standard adjuvant chemoradiotherapy. Approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive 4 additional 28-day cycles of immunotherapy, with Nivolumab on Day 0 and BMS-986253 on Days 0 and 14. Patients will then enter the extended treatment phase where they will receive nivolumab alone every 4 weeks for another 6 treatments.
Group II: Arm C: CY/GVAX with nivolumab and urelumabExperimental Treatment4 Interventions
Patients receive low-dose cyclophosphamide, nivolumab, and urelumab on day 0 and GVAX pancreatic cancer vaccine on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide, nivolumab, and urelumab on day 0 and the vaccine on day 1. Beginning approximately 28 days after vaccination, patients receive standard adjuvant chemoradiotherapy. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide, nivolumab, and urelumab on day 0 and GVAX on day 1. Treatment with cyclophosphamide, nivolumab, urelumab, and the vaccine repeats every 28 days for 4 courses. Patients will then enter the extended treatment phase where they will receive nivolumab and urelumab every 4 weeks for another 6 treatments as well as cyclophosphamide on day 0, and GVAX on day 1 every 12 weeks for another 2 treatments.
Group III: Arm B: CY/GVAX with nivolumabExperimental Treatment3 Interventions
Patients receive low-dose cyclophosphamide and nivolumab IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide and nivolumab IV on day 0 and the vaccine on day 1. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide and nivolumab IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide, nivolumab, and the vaccine repeats every 28 days for 4 courses. Patients will then enter the extended treatment phase where they will receive nivolumab every 4 weeks for another 6 treatments as well as cyclophosphamide on day 0, and GVAX on day 1 every 12 weeks for another 2 treatments.
Group IV: Arm A: CY/GVAX aloneExperimental Treatment2 Interventions
Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 courses. Patients will then enter the extended treatment phase where they will receive cyclophosphamide on day 0, and GVAX on day 1 every 12 weeks for another 2 treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Urelumab
2013
Completed Phase 1
~240
BMS-986253
2020
Completed Phase 2
~50
Nivolumab
2014
Completed Phase 3
~4740

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
563 Previous Clinical Trials
33,248 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,325 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,673 Total Patients Enrolled

Media Library

GVAX pancreatic cancer (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02451982 — Phase 2
Pancreatic Cancer Research Study Groups: Arm C: CY/GVAX with nivolumab and urelumab, Arm A: CY/GVAX alone, Arm D: BMS-986253 and Nivolumab, Arm B: CY/GVAX with nivolumab
Pancreatic Cancer Clinical Trial 2023: GVAX pancreatic cancer Highlights & Side Effects. Trial Name: NCT02451982 — Phase 2
GVAX pancreatic cancer (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02451982 — Phase 2
~4 spots leftby Dec 2024