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Cancer Vaccine

KRAS Peptide Vaccine for Pancreatic Cancer

Phase 1
Recruiting
Led By Neeha Zaidi, 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
High Risk Group 2 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher):
Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

Study Summary

This trial will test a new cancer vaccine made from mutated KRAS proteins and an adjuvant. They will study how safe it is and if it causes an immune response.

Who is the study for?
This trial is for adults at high risk of developing pancreatic cancer due to genetic mutations or family history. Participants must have a documented pancreatic abnormality and adequate organ function. Women of childbearing potential and men must follow contraceptive guidelines. Exclusions include pregnancy, breastfeeding, major surgery, infections like HIV or hepatitis B/C, immunodeficiency, recent receipt of vaccines or corticosteroids.Check my eligibility
What is being tested?
The study tests the safety and immune response to a KRAS peptide vaccine with poly-ICLC adjuvant in individuals who are genetically predisposed to pancreatic cancer. It's an early-phase trial designed to see if this vaccine can potentially prevent the development of cancer in those at high risk.See study design
What are the potential side effects?
As it's a Phase 1 study primarily assessing safety, specific side effects aren't listed but may include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I carry a gene mutation linked to a high risk of pancreatic cancer.
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My organ and bone marrow functions meet the required levels for the study.
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I am over 40 with a FAMMM mutation or over 50 with a BRCA2, ATM, PALB2 mutation and have proof.
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I am at high risk for pancreatic cancer and have a pancreatic cyst.
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I am being monitored for a pancreatic issue with regular scans.
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I am not pregnant and will follow the study's birth control requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 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
Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 and CD4 T cells
Number of participants experiencing study drug-related toxicities
Secondary outcome measures
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 weeks.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks.

Side effects data

From 2013 Phase 1 & 2 trial • 34 Patients • NCT01079741
100%
Injection site pain
100%
Injection site erythema
83%
Fatigue
75%
Influenza like illness
67%
Injection site discomfort
50%
Headache
50%
Injection site pruritus
50%
Injection site oedema
50%
Injection site nodule
50%
Chills
42%
Pain
33%
Pyrexia
33%
Myalgia
25%
Nausea
25%
Arthralgia
17%
Cough
17%
Injection site haemorrhage
17%
Dyspepsia
8%
Rash
8%
Rhinitis
8%
Oropharyngeal pain
8%
Chest discomfort
8%
Eye Injury
8%
Dysmenorrhoea
8%
Rash pruritic
8%
Seasonal allergy
8%
Diarrhea
8%
Toothache
8%
Night sweats
8%
Musculoskeletal chest pain
8%
Musculoskeletal discomfort
8%
Musculoskeletal pain
8%
Abdominal discomfort
8%
Nasal congestion
8%
Vision Blurred
8%
Coronary artery disease
8%
Nasopharyngitis
8%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2, Arm 1
Poly-ICLC 0.35 mg
Poly-ICLC 1.4mg
Phase 2, Arm 2
Poly-ICLC 0.70 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: KRAS peptide vaccineExperimental Treatment1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stand Up To CancerOTHER
51 Previous Clinical Trials
40,269 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,895 Total Patients Enrolled
Neeha Zaidi, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institution
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

KRAS peptide vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05013216 — Phase 1
Pancreatic Cancer Research Study Groups: KRAS peptide vaccine
Pancreatic Cancer Clinical Trial 2023: KRAS peptide vaccine Highlights & Side Effects. Trial Name: NCT05013216 — Phase 1
KRAS peptide vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05013216 — Phase 1

Frequently Asked Questions

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

What is the intake capacity for participants of this experiment?

"Affirmative. The clinicaltrials.gov website confirms that this medical trial, first posted on April 11th 2022, is actively enrolling patients across 1 site with a target of 25 participants in total."

Answered by AI

Is the KRAS peptide vaccine deemed secure by health experts?

"KRAS peptide vaccine has limited data regarding both safety and efficacy, so it is assigned a score of 1."

Answered by AI

Are there vacancies available in this investigation for participants?

"Indeed, the information on clinicaltrials.gov affirms that this medical trial is actively recruiting patients. The project was first posted on April 11th 2022 and has undergone recent modifications made as of October 5th 2022. There are 25 available positions being offered at a single site."

Answered by AI

What outcome is this medical experiment attempting to achieve?

"This two-year study seeks to measure the maximum percentage change of interferon (IFN-γ) producing mutant-KRAS specific CD8 and CD4 T cells. Secondary objectives include evaluating fold changes in interferon production at 13 weeks, 17 weeks, and determining the maximal percent change in IFN-γ production from pre-vaccination baseline."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Sidney Kimmel Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
2022. "Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05013216.
~12 spots leftby May 2026
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