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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
54%
Nausea
48%
Fatigue
37%
Diarrhoea
35%
Decreased appetite
24%
Vomiting
22%
Abdominal pain
20%
Palmar-plantar erythrodysaesthesia syndrome
19%
Constipation
17%
Pyrexia
17%
Anaemia
13%
Hypokalaemia
13%
Rash
11%
Dyspnoea
9%
Chills
9%
Dehydration
7%
Neuropathy peripheral
7%
Abdominal pain upper
7%
Thrombocytopenia
7%
Dry skin
7%
Urinary tract infection
6%
Dizziness
6%
Neutropenia
6%
Rhinorrhoea
6%
Anxiety
6%
Weight decreased
6%
Hyponatraemia
6%
Deep vein thrombosis
6%
Back pain
6%
Upper respiratory tract infection
4%
Flatulence
4%
Disease progression
4%
Abdominal distension
4%
Headache
4%
Pain
4%
Pulmonary embolism
4%
Tachycardia
4%
Abdominal Pain
4%
Oedema peripheral
4%
Asthenia
4%
Hypoalbuminaemia
4%
Hypomagnesaemia
4%
Blood alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Insomnia
4%
Confusional state
2%
Ileus
2%
Sepsis
2%
Haematemesis
2%
Ascites
2%
Hypercalcaemia
2%
Gastrooesophageal reflux disease
2%
Dry mouth
2%
Pain in extremity
2%
Pruritus
2%
Aspartate aminotransferase increased
2%
Sinus tachycardia
2%
Erythema
2%
Bile duct obstruction
2%
Alanine aminotransferase increased
2%
Hypoxia
2%
Arthralgia
2%
Gastrointestinal haemorrhage
2%
Colitis
2%
Fungal oesophagitis
2%
Hypophosphataemia
2%
Lymphocyte count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pooled Cohort: Chemotherapy
Pooled Cohort: Cy/GVAX + CRS-207
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
~3770
Nivolumab
2014
Completed Phase 3
~4750
GVAX Pancreas Vaccine
2018
Completed Phase 2
~400
Ipilimumab
2014
Completed Phase 3
~2620
CRS-207
2015
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,646 Previous Clinical Trials
4,131,081 Total Patients Enrolled
Aduro Biotech, Inc.Industry Sponsor
12 Previous Clinical Trials
743 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,379 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 May 2025
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