Non-Small Cell Lung CancerPhase 1NCT05254184

KRAS-Targeted Vaccine With Chemoimmunotherapy, Nivolumab and Ipilimumab for Patients With NSCLC

A Phase 1 study testing Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptides in people with Non-Small Cell Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptides
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2022to 1 Apr 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically- or cytologically-proven non-small cell lung cancer deemed to be locally advanced/unresectable or metastatic as per AJCC version 9, who has not received prior therapy for this stage of disease.
Must have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the Principal Investigator).
Measurable disease as defined by RECIST v1.1.
Have one of the KRAS mutations (KRASG12C, KRASG12V, KRASG12D, KRASG12A, KRASG13D or KRASG12R) included in the vaccine at the time of vaccination expressed in tumor as defined by a CLIA-certified tumor or plasma based genomic testing platform performed either through a local laboratory or through our central laboratory.
ECOG performance status 0 or 1.
Patients must have adequate organ and marrow function as defined below:

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Leukocytes ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,000/mcL
Platelets ≥ 75 × 103/uL
Hemoglobin ≥ 8.0 g/dL
Total bilirubin ≤ 1.5 x ULN (< 2.0 x ULN for subjects with documented Gilbert's syndrome)
AST(SGOT) and ALT(SGPT)≤ 2.5 × ULN (if liver metastases are present, £ 5 x ULN)
Alkaline phosphatase ≤5.0 × ULN
Creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
o Female CrCl = (140 - age in years) x weight in kg x 0.85
72 x serum creatinine in mg/dL
o Male CrCl = (140 - age in years) x weight in kg x 1.00
72 x serum creatinine in mg/dL
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)). WOCBP is defined in Section 4.6. NOTE: If a patient has a positive or indeterminate serum or urine pregnancy test, then an ultrasound must be done to rule out pregnancy to enroll on trial.
WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 4 weeks (duration of ovulatory cycle) for a total of 5 months post treatment completion.
Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion.
At least one barrier method of contraception must be employed by all sexually active patients (male and female), regardless of other methods, to prevent the transfer of body fluids.
Ability to understand and willingness to sign a written informed consent document.

Who cannot join

Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
Any of the following procedures or medications:
Within 2 weeks prior to initiation of study treatment:
Systemic or topical corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or equivalent). Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Palliative or adjuvant radiation or gamma knife radiosurgery.
Chemotherapy

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Within 4 weeks prior to initiation of study treatment:
Any investigational cytotoxic drug. Exposure to any cytotoxic drug within 4 weeks or 5 half-lives (whichever is shorter) is prohibited. If 5 half-lives are shorter than 4 weeks, agreement with IND Sponsor is mandatory.
Any investigational device
Non-oncology vaccines containing live virus. Examples include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid vaccine. Influenza, pneumonia vaccines (polysaccharide and conjugated forms) and COVID-19 vaccines will be allowed, however we recommend that subjects not receive any dose of vaccine within 7 days before or after their scheduled KRAS peptide vaccination.
Allergen hyposensitization therapy.
Growth factors, e.g. granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin
Major surgery (excludes celiac plexus block, biliary stent placement, and other minor procedures such as dental work, skin biopsy, etc.).
Patients with a history of prior treatment with immunotherapy agents (including, but not limited to: IL-2, interferon, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies).
Patients who have received anti-PD(L)-1 therapy (i.e. durvalumab, atezolizumab, nivolumab) for early-stage disease with curative intent may be enrolled, so long as progressive disease occurred at least 6 months from the start of anti-PD(L)-1 therapy. Patients with a history of immune-related adverse events secondary to prior anti-PD(L)-1 therapy will not be permitted.
History of severe hypersensitivity reaction to any monoclonal antibodies or related compounds or to any of their components (e.g., history of severe hypersensitivity reactions to drugs formulated with polysorbate 80). This includes any prior immunotherapy agents; patients having toxicity with prior anti-PD-L1 therapy requiring cessation of treatment must be excluded.
Untreated or symptomatic brain metastases.
Treated brain metastases allowed on study if asymptomatic and therapy was completed at least 2 weeks prior to treatment start, and steroid dosing outlined above.
Has an active known autoimmune disease or which has required systemic therapy in the last 2 years. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Known history of interstitial lung disease or of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Has a pulse oximetry < 90% on room air.
Requires the use of home oxygen.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV1/2 antibodies), hepatitis B, or hepatitis C infection.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness that would limit compliance with study requirements.
Patients who have been diagnosed with another cancer or myeloproliferative disorder in the past 5 years except for superficial bladder cancer, non-melanoma skin cancers, or a low-grade prostate cancer not requiring therapy.
Has a diagnosis of immunodeficiency.
Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoietic stem cell transplant will be excluded.
Any other sound medical or psychiatric reason as determined by the Investigator.
Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements.
Patient is unwilling or unable to follow the study schedule for any reason.
Patient is pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristen Marrone, MD contact

410-955-8964

ThoracicCancerTrials@jhmi.edu

United States1 site, 1 recruiting

Johns Hopkins University
Baltimore, Maryland, 21287
Kristen Marrone, MD, 410-955-8964, ThoracicCancerTrials@jhmi.edu
Recruiting

Other trials in United States

About this study

Official title: Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Chemotherapy, Nivolumab and Ipilimumab for Patients With Advanced KRAS Mutated Non-Small Cell Lung Cancer

This is a single institution, Phase 1 study for patients with Stage III/IV unresectable Kirsten rat sarcoma (KRAS) mutated NSCLC to evaluate safety of the pooled mutant-KRAS peptide vaccine (KRAS peptide vaccine) with polyinosinic-polycytidylic acid (poly-ICLC) adjuvant in combination with chemoimmunotherapy, nivolumab and ipilimumab in the first line treatment setting. The primary objectives of this study are to determine the safety and feasibility of administering the KRAS peptide vaccine with poly-ICLC adjuvant with chemoimmunotherapy nivolumab and ipilimumab. The secondary objectives are to estimate the progression free survival (PFS) of pooled mutant-KRAS long peptide vaccine with poly-ICLC adjuvant in combination with chemoimmunotherapy, Nivolumab + Ipilimumab for the first line treatment of patients with unresectable Stage III/IV NSCLC whose tumors harbor selected KRAS mutations (KRAS glycine-to-cysteine substitution at codon 12 (G12C), KRAS glycine-to-valine substitution at codon 12 (G12V), KRAS glycine-to-aspartate substitution at codon 12 (G12D), KRAS glycine-to-arginine substitution at codon 12 (G12A), KRAS glycine-to-Aspartate "D" at codon 13 (G13D) or KRAS G12R) and to assess the impact of predicted KRAS mutations on mutant-KRAS specific T cell responses in the peripheral blood of these patients. Participants will receive two doses of chemoimmunotherapy followed by KRAS-targeted vaccine with ipilimumab and nivolumab. Exploratory objectives will assess the impact of predicted KRAS mutations on mutant-KRAS specific T cell responses in the peripheral blood, as well as changes in circulating tumor deoxyribonucleic acid (ctDNA). Approximately 15 subjects will be enrolled to have 12 evaluable subjects for T cell response assessment. Safety analysis will include all enrolled patients who receive at least one dose of vaccine. The evaluable population for T cell response will consist of all patients who receive at least one dose of vaccine and have baseline and post-treatment T cell measures in the peripheral blood at 12 weeks.

Conditions: Non-Small Cell Lung Cancer
Being tested: Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptides
Keywords: Advanced KRAS mutated Non-Small Cell Lung Cancer
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptidesDrug
Also called Nivolumab 3 mg/kg every 2 weeks, Ipilimumab 1 mg/kg every 6 weeks, Carboplatin AUC 4 or 5 every 3 weeks, Paclitaxel 175 mg/m2 or 200 mg/m2 every 3 weeks
administering the KRAS peptide vaccine with poly-ICLC adjuvant in combination with chemoimmunotherapy, nivolumab and ipilimumab

Study groups in NCT05254184
Study group	Role	What they receive
Patients With NSCLC	Experimental	All participants will receive the intervention. Receives: Drug: Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptides

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab as assessed by adverse events.
The safety of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab will be assessed by the occurrence of the following adverse events:
- Grade 3 or above drug-related toxicities
- Drug-related toxicity by grade
- Vaccine site reactions after KRAS injections
- Nivolumab-related infusion reactions
- Ipilimumab-related infusion reactions
- Immune-related adverse events (AEs)
- Unacceptable toxicities
- Treatment-emergent changes from normal to abnormal values in key
- laboratory parameters
Measured: Up to day 29
Feasibility of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab as assessed by adverse events.
Feasibility of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab will be assessed by the occurrence of the following adverse events:
- Grade 3 or above drug-related toxicities
- Drug-related toxicity by grade
- Vaccine site reactions after KRAS injections
- Nivolumab-related infusion reactions
- Ipilimumab-related infusion reactions
- Immune-related adverse events (AEs)
- Unacceptable toxicities
- Treatment-emergent changes from normal to abnormal values in key
- laboratory parameters
Measured: Up to 29 days

Secondary outcomes (3)

Progression Free Survival (PFS) as assessed by imaging
PFS as defined as the time from first vaccination to the earliest evidence of progressive disease (based on imaging) or death from any cause as determined by medical history and physical examination in combination with imaging evaluation, cytology, or tissue biopsy.
Measured: Baseline to progression, up to 4 years
Change in interferon-producing mutant-KRAS-specific cluster of differentiation (CD) 8 T cells in the peripheral blood
T cell response will be evaluated by the fold change in interferon-producing mutant-KRAS-specific CD 8 T cells in the peripheral blood.
Measured: Pre-vaccination baseline to end of treatment, up to 2 years
Change in interferon-producing mutant-KRAS-specific CD 4 T cells in the peripheral blood
T cell response will be evaluated by the fold change in interferon-producing mutant-KRAS-specific CD 4 T cells in the peripheral blood.
Measured: Pre-vaccination baseline to end of treatment, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20221 Apr 2027

First posted24 Feb 2022
Study start1 Nov 2022
Primary completion1 Apr 2027 (estimated)
Study completion1 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05254184
Sponsor's protocol ID: J21131
Other IDs: IRB00306311
Status last verified: Mar 2026
First submitted: 14 Feb 2022
Last updated: 30 Mar 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Chemotherapy, Nivolumab and Ipilimumab for Patients With Advanced KRAS Mutated Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05254184
Acronym / sponsor ID: J21131
Conditions: Non-Small Cell Lung Cancer
Keywords: Advanced KRAS mutated Non-Small Cell Lung Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Study start: 1 Nov 2022 (actual)
Primary completion: 1 Apr 2027 (estimated)
Study completion: 1 Apr 2027 (estimated)
First posted: 24 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients With NSCLC	Experimental	Drug: Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptidesAll participants will receive the intervention.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Histologically- or cytologically-proven non-small cell lung cancer deemed to be locally advanced/unresectable or metastatic as per AJCC version 9, who has not received prior therapy for this stage of disease.
Must have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the Principal Investigator).
Measurable disease as defined by RECIST v1.1.
Have one of the KRAS mutations (KRASG12C, KRASG12V, KRASG12D, KRASG12A, KRASG13D or KRASG12R) included in the vaccine at the time of vaccination expressed in tumor as defined by a CLIA-certified tumor or plasma based genomic testing platform performed either through a local laboratory or through our central laboratory.
ECOG performance status 0 or 1.

Key exclusion criteria (31 listed)

Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
Any of the following procedures or medications:
Within 2 weeks prior to initiation of study treatment:
Systemic or topical corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or equivalent). Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Palliative or adjuvant radiation or gamma knife radiosurgery.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pooled Mutant KRAS-Targeted Long Peptide Vaccine 0.3mg each; 1.8mg total peptidesAlso: Nivolumab 3 mg/kg every 2 weeks, Ipilimumab 1 mg/kg every 6 weeks, Carboplatin AUC 4 or 5 every 3 weeks, Paclitaxel 175 mg/m2 or 200 mg/m2 every 3 weeksadministering the KRAS peptide vaccine with poly-ICLC adjuvant in combination with chemoimmunotherapy, nivolumab and ipilimumab	Drug	Patients With NSCLC

Primary outcome

Safety of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab as assessed by adverse events.
Time frame: Up to day 29
The safety of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab will be assessed by the occurrence of the following adverse events: * Grade 3 or above drug-related toxicities * Drug-related toxicity by grade * Vaccine site reactions after KRAS injections * Nivolumab-related infusion reactions * Ipilimumab-related infusion reactions * Immune-related adverse events (AEs) * Unacceptable toxicities * Treatment-emergent changes from normal to abnormal values in key * laboratory parameters
Feasibility of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab as assessed by adverse events.
Time frame: Up to 29 days
Feasibility of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab will be assessed by the occurrence of the following adverse events: * Grade 3 or above drug-related toxicities * Drug-related toxicity by grade * Vaccine site reactions after KRAS injections * Nivolumab-related infusion reactions * Ipilimumab-related infusion reactions * Immune-related adverse events (AEs) * Unacceptable toxicities * Treatment-emergent changes from normal to abnormal values in key * laboratory parameters

3 secondary outcomes

Progression Free Survival (PFS) as assessed by imaging
Time frame: Baseline to progression, up to 4 years
Change in interferon-producing mutant-KRAS-specific cluster of differentiation (CD) 8 T cells in the peripheral blood
Time frame: Pre-vaccination baseline to end of treatment, up to 2 years
Change in interferon-producing mutant-KRAS-specific CD 4 T cells in the peripheral blood
Time frame: Pre-vaccination baseline to end of treatment, up to 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Kristen Marrone, MD contact

410-955-8964

ThoracicCancerTrials@jhmi.edu

Kristen Marrone, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristen Marrone, MD (410-955-8964, ThoracicCancerTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of administering a KRAS peptide vaccine in combination with chemoimmunotherapy, nivolumab and ipilimumab as assessed by adverse events. (time frame: Up to day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05254184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.