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Cancer Vaccine

Immunotherapy for Pancreatic Cancer

Q: Has GVAX pancreatic cancer been granted regulatory clearance by the FDA?

<p>Our team at Power rated GVAX <a href="https://www.withpower.com/clinical-trials/pancreatic-cancer">pancreatic cancer</a>'s safety a 2, as there are Phase 2 study results that attest to its security yet lack of efficacy data.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

Nivolumab

2014

Completed Phase 3

~4750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,844 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,929 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,129,988 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 D: BMS-986253 and Nivolumab, Arm C: CY/GVAX with nivolumab and urelumab, Arm A: CY/GVAX alone, 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

Frequently Asked Questions

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

Are there any other documented experiments that have utilized GVAX pancreatic cancer treatments?

"Currently, there are 1510 active studies examining GVAX pancreatic cancer. Of these trials, 234 have reached Phase 3 and the majority of them are located in Philadelphia, Pennsylvania. On a global scale, 67193 different sites are running experiments for this drug's efficacy."

Answered by AI

What medical purpose has GVAX pancreatic cancer proven effective for?

"GVAX pancreatic cancer is traditionally administered to patients suffering from multiple sclerosis. Moreover, it can be effective at combatting leukemias and various malignant neoplasms including unresectable melanoma."

Answered by AI

Is the research project still open to participant recruitment?

"Accurately, clinicaltrials.gov states that the trial is actively enrolling participants. The research project was initially posted on 28th March 2016 and recently updated on 2nd May 2022. 76 eligible patients are needed for this medical investigation at one locale."

Answered by AI

What is the maximum capacity for participants in this investigation?

"Affirmative. The information on clinicaltrials.gov reveals that this medical research, which was initially released on March 28th 2016, is currently pursuing enrolment. 76 participants are anticipated to join the study across a single site."

Answered by AI

Has GVAX pancreatic cancer been granted regulatory clearance by the FDA?

"Our team at Power rated GVAX pancreatic cancer's safety a 2, as there are Phase 2 study results that attest to its security yet lack of efficacy data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

2016. "Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02451982.

All > Pancreatic Cancer