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Cancer Vaccine

CRS-207 for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Dung Le, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 months
Awards & highlights

Study Summary

This trial is testing a combination of two drugs, nivolumab and ipilimumab, with either a vaccine or another drug, CRS-207, to treat pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
Secondary outcome measures
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)

Side effects data

From 2016 Phase 2 trial • 303 Patients • NCT02004262
82%
Vaccination site erythema
63%
Chills
56%
Vaccination site pain
56%
Vaccination site induration
54%
Pyrexia
54%
Vaccination site oedema
53%
Fatigue
52%
Vaccination site pruritus
45%
Nausea
34%
Vomiting
32%
Abdominal pain
27%
Constipation
27%
Vaccination site bruising
26%
Decreased appetite
20%
Anaemia
19%
Headache
19%
Hypotension
19%
Blood alkaline phosphatase increased
19%
Back pain
18%
Aspartate aminotransferase increased
16%
Oedema peripheral
14%
Disease progression
14%
Tachycardia
14%
Hyponatraemia
13%
Diarrhoea
13%
Alanine aminotransferase increased
13%
Thrombocytopenia
12%
Pruritus
11%
Weight decreased
11%
Hypertension
10%
Abdominal distension
10%
Insomnia
9%
Blood bilirubin increased
9%
Flatulence
9%
Ascites
9%
Erythema
9%
Abdominal pain upper
9%
Dehydration
9%
Hypoalbuminaemia
9%
Dyspnoea
9%
Pain
7%
Hypokalaemia
7%
Dizziness
7%
Myalgia
7%
Lymphocyte count decreased
6%
Gastrooesophageal reflux disease
6%
Hypoxia
6%
Pain in extremity
6%
Vaccination site vesicles
6%
Arthralgia
6%
Hypomagnesaemia
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Blood creatinine increased
6%
Pulmonary embolism
5%
Asthenia
5%
Night sweats
5%
Hypophosphataemia
5%
Blood albumin decreased
5%
Blood sodium decreased
5%
International normalised ratio increased
5%
Leukocytosis
5%
Deep vein thrombosis
5%
Confusional state
5%
Bile duct obstruction
4%
Abdominal Pain
3%
Sinus tachycardia
3%
Dry mouth
3%
Neuropathy peripheral
3%
Dry skin
3%
Urinary tract infection
3%
Upper respiratory tract infection
2%
Upper gastrointestinal haemorrhage
2%
Cough
2%
Cholangitis
2%
Cerebrovascular accident
2%
Anxiety
2%
Malignant pleural effusion
1%
Pneumonia
1%
Death
1%
Renal failure acute
1%
Failure to thrive
1%
Hallucination
1%
Haemorrhage
1%
Atrial fibrillation
1%
Hyperbilirubinaemia
1%
Hip fracture
1%
Myocardial infarction
1%
Gastrointestinal anastomotic complication
1%
Neutropenia
1%
Memory impairment
1%
Spinal cord compression
1%
Rash
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Gastritis
1%
Lower gastrointestinal haemorrhage
1%
Device dislocation
1%
Jaundice cholestatic
1%
Sepsis
1%
Herpes zoster
1%
Klebsiella sepsis
1%
Syncope
1%
Cerebral haemorrhage
1%
Transient ischaemic attack
1%
Superior vena cava syndrome
1%
Acute myocardial infarction
1%
Mental status changes
1%
Musculoskeletal chest pain
1%
Small intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pooled Cohort: Cy/GVAX + CRS-207
Pooled Cohort: Chemotherapy
Pooled Cohort: CRS-207

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Nivolumab, Ipilimumab, CRS-207Experimental Treatment3 Interventions
Group II: Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207Experimental Treatment5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Nivolumab
2014
Completed Phase 3
~4750
GVAX Pancreas Vaccine
2018
Completed Phase 2
~400
Ipilimumab
2014
Completed Phase 3
~2670
CRS-207
2015
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,453 Total Patients Enrolled
Aduro Biotech, Inc.Industry Sponsor
12 Previous Clinical Trials
743 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,092 Total Patients Enrolled

Media Library

CRS-207 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03190265 — Phase 2
Pancreatic Cancer Research Study Groups: Arm B: Nivolumab, Ipilimumab, CRS-207, Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Pancreatic Cancer Clinical Trial 2023: CRS-207 Highlights & Side Effects. Trial Name: NCT03190265 — Phase 2
CRS-207 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03190265 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
2017. "Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03190265.
~8 spots leftby Apr 2025
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