Is NCT05269381 recruiting in Jacksonville, FL?

Yes, NCT05269381 is currently recruiting participants at its Jacksonville, FL location. This anatomic stage iii breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial in Jacksonville, FL

Q: How do I join the anatomic stage iii breast cancer ajcc v8 clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Anatomic Stage III Breast Cancer AJCC v8 Study in Jacksonville

This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

COHORT 1 and COHORT 2 are no longer enrolling. PHASE I PRE-REGISTRATION, ALL:

Willing to provide tissue specimens per protocol

NOTE: includes fresh tissue specimen at pre-registration for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo Institutional Review Board (IRB) protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and/or registration.

Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease

NOTE: Tumor lesions in previously irradiated area are not considered measurable disease

Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy

Provide written informed consent

Willing to return to enrolling institution for follow-up

Willing to provide blood specimens for research

Negative pregnancy test =\< 7 days prior to pre-registration for persons of childbearing potential. If urine test cannot be confirmed negative, serum pregnancy test will be required.

Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle

Willing to receive tetanus vaccination if subject has not had one =\< 1 year prior to pre-registration

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

Anticipated life expectancy \> 6 months

Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).

The following lab values obtained =\< 28 days prior to pre-registration:

Hemoglobin \>= 9.0 g/dL (Must be \>= 7 days after most recent transfusion)

Absolute neutrophil count (ANC) \>= 1500/mm\^3 or \>= 1.5 X 10\^9/L

Platelet count \>= 100,000/mm\^3 or \>= 100 X 10\^9/L (Must be \>=7 days after most recent transfusion)

Total bilirubin =\< 1.5 x upper limit of normal (ULN)

Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3 x ULN or =\< 5 x ULN with liver metastases

Creatinine =\< 1.5 x ULN OR calculated creatinine clearance must be \>= 50 ml/min using Cockcroft-Gault formula

International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy PHASE I REGISTRATION, ALL:

Successful sequencing and production of REAL-Neo vaccine

Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease

NOTE: Tumor lesions in previously irradiated area are not considered measurable disease

ECOG PS 0 or 1

Anticipated life expectancy \> 6 months

The following lab values obtained =\< 14 days prior to registration:

Hemoglobin \>= 9.0 g/dl

ANC \>= 1500/mm\^3

Platelet count \>= 100,000/mm\^3

Total bilirubin =\< 1.5 x ULN

ALT and AST =\< 3 x ULN (=\< 5 x ULN with liver involvement)

PT/INR and aPTT =\< 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy

Calculated creatinine clearance \>= 50 ml/min using Cockcroft-Gault formula

Provide written informed consent

Willing to provide blood and tissue specimens for research

Willing to return to enrolling institution for follow-up

Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy

Negative pregnancy test =\< 14 days prior to registration for persons of childbearing potential only

NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required

Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle

Willing to receive tetanus vaccination if subject has not had one =\< 1 year prior to pre-registration

Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see specified limits for inclusion) or NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo) PHASE II PRE-SCREENING COHORT 3 ONLY:

ECOG PS 0 or 1

Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \< 10%, progesterone receptor (PR) \< 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline

Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)

Evidence of residual disease \>= 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery

Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery

Provide written informed consent

Willing to return to enrolling institution for follow-up PHASE II PRE-SCREENING COHORT 4 ONLY:

ECOG PS 0 or 1

Histological confirmation of lung NSCLC

No actionable EGFR mutations and ALK fusions

Stage II or stage III based on AJCC 8th

Tumor \>= 2 cm on pre-surgery evaluation imaging (residual disease \>= 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed

Provide written informed consent

Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery

Willing to return to enrolling institution for follow-up PHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:

Histologically confirmed residual cancer burden 2 and 3 in surgical specimens PHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:

Tumor without complete pathologic response is confirmed in pathology

Willing to proceed with surgery and provide tissue specimens for complete exome and transcriptome sequencing

NOTE: Patients who had sequencing under certain Mayo IRB protocols and neoantigens identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and/or registration

Negative pregnancy test ≤7 days prior to pre-registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.

Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle

ECOG PS of 0 or 1

Anticipated life expectancy \> 6 months PHASE II REGISTRATION:

Successful sequencing and production of REAL-Neo vaccine

Patients will receive \>= 2 additional cycles of maintenance pembrolizumab

ECOG PS 0 or 1

Anticipated life expectancy \> 6 months

The following lab values obtained =\< 14 days prior to registration:

Hemoglobin \>= 9.0 g/dl

ANC \>= 1500/mm\^3

Platelet count \>= 100,000/mm\^3

Total bilirubin =\< 1.5 x ULN

ALT and AST =\< 3 x ULN (=\< 5 x ULN with liver involvement)

PT/INR and aPTT =\< 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy

Calculated creatinine clearance \>= 50 ml/min using Cockcroft-Gault formula

Provide written informed consent

Willing to provide blood specimens for research

Willing to return to enrolling institution for follow-up

Negative pregnancy test =\< 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.

Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle

Willing to receive tetanus vaccination if subject has not had one =\< 1 year prior registration

Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)

Exclusion Criteria

ALL PHASES:

Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:

Pregnant person

Nursing person unwilling to stop breast feeding

Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle

Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens

History of myocardial infarction =\< 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.

Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy PHASE I PRE-REGISTRATION:

Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment

Uncontrolled illness including, but not limited to:

Ongoing or active infection

Psychiatric illness/social situations

Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease

Stroke =\< 3 months prior to pre-registration

Significant cardiac arrhythmia or unstable angina

Any other conditions that would limit compliance with study requirements

Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab

Any prior hypersensitivity or adverse reaction to GM-CSF

Other active malignancy =\< 3 years prior to pre-registration

EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix

NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer

History of active autoimmune disease (AD) that required systemic treatment in =\< 30 days (i.e., use of disease modifying agents, corticosteroids \> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration

NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION

Any of the following prior therapies:

Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\< 3 weeks prior to registration

Radiation =\< 2 weeks prior to registration

Major Surgery =\< 4 weeks prior to registration

Received live vaccine =\< 30 days prior to registration

Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \> 14 days from first dose of vaccination on study

CTCAE \>= Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity

Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis

Active ADs that require chronic systemic steroids (\> 10 mg daily prednisone equivalent) or immunosuppressive agents

Systemic corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\< 14 days prior to registration

NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent permitted in absence of active AD

Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \>10 mg daily prednisone equivalent

NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan) PHASE II PRE-SCREENING:

Uncontrolled illness including, but not limited to:

Ongoing or active infection

Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease

Significant cardiac arrhythmia or unstable angina

Any other conditions that would limit compliance with study requirements

Any prior hypersensitivity or adverse reaction to GM-CSF

Other active malignancy =\< 3 years prior to pre-screening

EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix

NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer

Known history of active AD that has required systemic treatment in the =\< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening

NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded. PHASE II PRE-REGISTRATION

Uncontrolled illness including, but not limited to:

Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease

Significant cardiac arrhythmia or unstable angina

Any other conditions that would limit compliance with study requirements

Any prior hypersensitivity or adverse reaction to GM-CSF

Other active malignancy =\< 3 years prior to pre-registration

EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix

NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer

Known history of active AD that has required systemic treatment in the =\< 30 days (i.e., with use of disease modifying agents, corticosteroids \> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration

NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.

Patients will also be excluded based on tissue/ribonucleic acid (RNA)/deoxyribonucleic acid (DNA) quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are \>= 2 cores with passing cellularity; (3) \>= 30% of tumor RNA with fragment sizes are \>= 200 base pairs (DV200 \>= 30); (4) \< 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.) PHASE II REGISTRATION

Evidence of metastatic disease or recurrence

Any of the following prior therapies:

Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\< 3 weeks prior to registration

Radiation =\< 2 weeks prior to registration

Major surgery =\< 4 weeks prior to registration

Received live vaccine =\< 30 days prior to registration

NOTE: Continuation of pembrolizumab per standard of care is allowed

NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \> 14 days from first dose of vaccination on study

CTCAE \>= grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity

Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis

Active ADs that require chronic systemic steroids (\> 10 mg daily prednisone equivalent) or immunosuppressive agents

Requirement for systemic corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\< 14 days prior to registration

NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT05269381) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anatomic Stage III Breast Cancer AJCC v8 Treatment Options in Jacksonville, FL

If you're searching for anatomic stage iii breast cancer ajcc v8 treatment options in Jacksonville, FL, this clinical trial (NCT05269381) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anatomic stage iii breast cancer ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anatomic stage iii breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial in Jacksonville, FL

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Why Participate?

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About This Anatomic Stage III Breast Cancer AJCC v8 Study in Jacksonville

Who Can Participate

Inclusion Criteria

Exclusion Criteria

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Q:Is it safe to participate?

Q:Will I be compensated?

Q:Can I leave the trial if I change my mind?

Anatomic Stage III Breast Cancer AJCC v8 Treatment Options in Jacksonville, FL

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