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Cancer Vaccine

Immunotherapy for Pancreatic Cancer

Phase 2

Recruiting

Led By Ana De Jesus-Acosta, 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

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

No Placebo-Only Group

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IL17A expression

Intratumoral CD8+CD137+cells

Intratumoral granzyme B+PD-1+CD137+ cells

+1 more

Secondary study objectives

Disease Free Survival

Drug-Related Adverse Events

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

Urelumab

2013

Completed Phase 1

~240