Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Merkel Cell Carcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Cervical Carcinoma, Locally Advanced Endometrial Carcinoma, Locally Advanced Gastric Adenocarcinoma, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hepatocellular Carcinoma, Locally Advanced Lung Non-Small Cell Carcinoma, Locally Advanced Malignant Solid Neoplasm, Locally Advanced Melanoma, Locally Advanced Merkel Cell Carcinoma, Locally Advanced Renal Cell Carcinoma, Locally Advanced Skin Squamous Cell Carcinoma, Locally Advanced Triple-Negative Breast Carcinoma, Locally Advanced Unresectable Breast Carcinoma, Locally Advanced Unresectable Cervical Carcinoma, Locally Advanced Unresectable Gastric Adenocarcinoma, Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma, Locally Advanced Unresectable Renal Cell Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Cervical Carcinoma, Metastatic Endometrial Carcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Merkel Cell Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma, Metastatic Triple-Negative Breast Carcinoma, Metastatic Urothelial Carcinoma, Skin Squamous Cell Carcinoma, Stage III Cervical Cancer AJCC v8, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage IIIA Cervical Cancer AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIA Uterine Corpus Cancer AJCC v8, Stage IIIB Cervical Cancer AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIB Uterine Corpus Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IIIC Uterine Corpus Cancer AJCC v8, Stage IIIC1 Uterine Corpus Cancer AJCC v8, Stage IIIC2 Uterine Corpus Cancer AJCC v8, Stage IV Cervical Cancer AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Stage IVA Cervical Cancer AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVA Uterine Corpus Cancer AJCC v8, Stage IVB Cervical Cancer AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IVB Uterine Corpus Cancer AJCC v8, Triple-Negative Breast Carcinoma, Unresectable Cervical Carcinoma, Unresectable Endometrial Carcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma, Unresectable Head and Neck Squamous Cell Carcinoma, Unresectable Hepatocellular Carcinoma, Unresectable Lung Non-Small Cell Carcinoma, Unresectable Malignant Solid Neoplasm, Unresectable Melanoma, Unresectable Merkel Cell Carcinoma, Unresectable Renal Cell Carcinoma, Unresectable Skin Squamous Cell Carcinoma, Unresectable Triple-Negative Breast Carcinoma, Unresectable Urothelial Carcinoma, Breast Adenocarcinoma, Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8

In brief

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.

Key facts

Study ID: NCT05269381
Run by: Mayo Clinic
People needed: 132
Starts: 2022-03-31
Expected to finish: 2028-03-31
Last updated by the study team: 2026-06-23

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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:

Where it is running

Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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