Your session is about to expire
← Back to Search
Checkpoint Inhibitor
KRAS Vaccine + Immunotherapy for Lung Cancer
Phase 1
Recruiting
Led By Kristen Marrone, 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
Histologically- or cytologically-proven adenocarcinoma of the lung deemed to be locally advanced/unresectable or metastatic as per American Joint Committee on Cancer (AJCC) version 8, who has not received prior therapy for this stage of disease.
Have one of the six KRAS mutations (KRAS G12C, KRAS G12V, KRAS G12D, KRAS G12A, KRAS G13D or KRAS G12R) in vaccine expressed in tumor as defined by a Clinical Laboratory Improvement Amendments (CLIA) certified tumor or plasma based genomic testing platform performed either through a local laboratory or through the investigators' central laboratory.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to progression, up to 4 years
Awards & highlights
Study Summary
This trial is testing a vaccine for people with a certain type of lung cancer. The vaccine is given with two other drugs, and the goal is to see if it is safe and if it helps patients live without their cancer progressing.
Who is the study for?
Adults with advanced, inoperable KRAS-mutated non-small cell lung cancer (NSCLC) who haven't had prior treatment for this stage. Participants must have tumors that can be biopsied, good physical health (ECOG 0 or 1), and proper organ function. Women of childbearing age and sexually active men must agree to contraception use.Check my eligibility
What is being tested?
The trial is testing a new vaccine targeting specific KRAS mutations in NSCLC combined with the immune checkpoint inhibitors nivolumab and ipilimumab. It aims to assess safety, feasibility, and how well it prevents disease progression.See study design
What are the potential side effects?
Potential side effects include typical reactions from vaccines such as soreness at injection site, fatigue, flu-like symptoms; plus risks from immunotherapy like inflammation in organs, skin issues, hormonal changes or autoimmune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced and has not been treated yet.
Select...
My tumor has one of the six specific KRAS mutations.
Select...
I am using at least one barrier method of contraception.
Select...
I received my last chemotherapy or radiation therapy less than 6 months ago.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to progression, up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to progression, up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of administering a KRAS peptide vaccine in combination with nivolumab and ipilimumab as assessed by adverse events
Safety of administering a KRAS peptide vaccine in combination with nivolumab and ipilimumab as assessed by adverse events
Secondary outcome measures
Change in interferon-producing mutant-KRAS-specific CD 4 T cells in the peripheral blood
Change in interferon-producing mutant-KRAS-specific cluster of differentiation (CD) 8 T cells in the peripheral blood
Progression Free Survival (PFS) as assessed by imaging
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients With NSCLCExperimental Treatment1 Intervention
All participants will receive the intervention.
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,908 Total Patients Enrolled
Kristen Marrone, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an immune system disorder.Women who could become pregnant must have a negative pregnancy test. If the test is positive or uncertain, an ultrasound must be done to confirm if the person is pregnant before joining the study.My lung cancer is advanced and has not been treated yet.I haven't had cancer or blood disorders in the last 5 years, except for certain low-risk types.My brain metastases are treated, I'm symptom-free, and it's been 2 weeks since my last therapy.I have an autoimmune disease but it's either mild or treated with only hormone replacement.My tumor has one of the six specific KRAS mutations.I am using at least one barrier method of contraception.I have not had any organ or tissue transplants, including bone marrow.I have a history of HIV, hepatitis B, or hepatitis C.Your oxygen level is less than 90% when breathing normally.I have brain metastases that haven't been treated or are causing symptoms.You have a disease that can be measured using specific guidelines called RECIST v1.1.I agree to have multiple biopsies of my cancer if it's safe.I will not need any other cancer treatments during the study.My organs and bone marrow are working well.I received my last chemotherapy or radiation therapy less than 6 months ago.I do not have any serious illnesses that could interfere with the study.I am fully active or restricted in physically strenuous activity but can do light work.I am unable or unwilling to follow the study's schedule.I have had lung inflammation that needed steroids or have it now.I am 18 years old or older.I agree to use contraception during and for 7 months after treatment if I'm sexually active with women who can become pregnant.I had early stage lung cancer treatment and my condition worsened 6 months after anti-PD-L1 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Patients With NSCLC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Might I be qualified to join this research?
"This study is currently recruiting 12 individuals with carcinoma, non-small-cell lung between the age of 18 and 100. Eligible participants must meet a range of criteria including: histologically or cytologically proven adenocarcinoma as per AJCC version 8; having received prior therapy for early stage NSCLC; having accessible tumor lesions amenable to biopsy; measurable disease according to RECIST v1.1.; belonging one of six KRAS mutations (KRAS G12C, KRAS G12V, KRAS G12D, KRAS G13A ,KRAS G13D or KRSAG"
Answered by AI
Is this study open to participants who have attained the age of majority?
"According to the requirements listed in this clinical trial, prospective participants must be aged 18-100."
Answered by AI
Is this experiment currently open to new enrollees?
"Per clinicaltrials.gov, this medical trial is not currently enrolling patients; the initial post date was on September 1st 2022 and the most recent edit was made August 18th 2022. However, there are many other trials actively recruiting for participants at present--over 2000 in total."
Answered by AI
Has the Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptides been authorized for use by the FDA?
"Our team at Power has rated the safety of Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptides a score of 1, due to its Phase 1 status which indicates that there is limited data regarding efficacy and safety available."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger