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Monoclonal Antibodies

KRAS Vaccine Combo for Colorectal and Pancreatic Cancer

Phase 1
Recruiting
Led By Nilofer Azad, 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
Sufficient and accessible tissue for next generation sequencing (NGS) and immune-phenotyping
Negative pregnancy test for women of childbearing potential
Must not have
Candidate for definitive surgical resection
Active autoimmune disease requiring systemic treatment in the past 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new vaccine combined with two other drugs for patients with advanced colorectal or pancreatic cancer. The goal is to see if this combination treatment is effective in patients whose cancer cannot be surg

Who is the study for?
This trial is for patients with stage IV MMR-p colorectal or pancreatic ductal cancer who have measurable disease after first-line FOLFIRINOX/FOLFOXIRI treatment. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.
What is being tested?
The study is testing a new KRAS vaccine combined with two immunotherapy drugs: Balstilimab and Botensilimab. It's in phase 1 to see how effective this combo is against certain types of advanced colorectal and pancreatic cancers.
What are the potential side effects?
Potential side effects may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue; immune-related responses from Balstilimab and Botensilimab could involve skin rash, diarrhea, liver inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer tissue is available for advanced genetic testing.
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I am not pregnant.
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My cancer originates from the pancreas or colon.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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I've had 4-6 months of FOLFIRINOX for my advanced pancreatic or colorectal cancer.
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My tumor has a specific KRAS mutation targeted by the vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am eligible for surgery to remove my cancer.
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I have not needed treatment for an autoimmune disease in the last 5 years.
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I have not been diagnosed with another cancer or blood disorder in the last 5 years.
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I have or had lung disease not related to cancer.
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I am not infected with HIV, hepatitis B, or C.
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I have been treated with immunotherapy before.
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I haven't taken immunosuppressants or steroids regularly in the last 14 days.
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I have not received a live vaccine in the last 28 days.
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I have had a cancer-related blockage in my small intestine.
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My cancer has spread to my brain or the protective layers of the brain.
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I do not have any uncontrolled illnesses.
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I have fluid buildup in my chest or abdomen.
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I haven't had major surgery within the last 28 days.
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I am receiving nutrition through an IV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Number of participants experiencing study drug-related toxicities
Objective Response Rate (ORR)
Progression-free Survival (PFS)
Secondary study objectives
Disease Control Rate (DCR)
Objective Response Rate (ORR) per RECIST 1.1
Progression-free Survival (PFS) per RECIST 1.1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SLP mKRASvax (Up to 1.8mg peptide + 0.5 mg Poly-ICLC (Hiltonol), Botensilimab and BalstilimabExperimental Treatment3 Interventions

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,180 Total Patients Enrolled
Agenus Inc.Industry Sponsor
52 Previous Clinical Trials
4,766 Total Patients Enrolled
Private Philanthropic FundsUNKNOWN
3 Previous Clinical Trials
97 Total Patients Enrolled
~33 spots leftby Nov 2027
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