Health Trials

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

ConditionsAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Merkel Cell Carcinoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Merkel Cell Carcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Locally Advanced Cervical CarcinomaLocally Advanced Endometrial CarcinomaLocally Advanced Gastric AdenocarcinomaLocally Advanced Gastroesophageal Junction AdenocarcinomaLocally Advanced Head and Neck Squamous Cell CarcinomaLocally Advanced Hepatocellular CarcinomaLocally Advanced Lung Non-Small Cell CarcinomaLocally Advanced Malignant Solid NeoplasmLocally Advanced MelanomaLocally Advanced Merkel Cell CarcinomaLocally Advanced Renal Cell CarcinomaLocally Advanced Skin Squamous Cell CarcinomaLocally Advanced Triple-Negative Breast CarcinomaLocally Advanced Unresectable Breast CarcinomaLocally Advanced Unresectable Cervical CarcinomaLocally Advanced Unresectable Gastric AdenocarcinomaLocally Advanced Unresectable Gastroesophageal Junction AdenocarcinomaLocally Advanced Unresectable Renal Cell CarcinomaLocally Advanced Urothelial CarcinomaMetastatic Cervical CarcinomaMetastatic Endometrial CarcinomaMetastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hepatocellular CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Merkel Cell CarcinomaMetastatic Renal Cell CarcinomaMetastatic Skin Squamous Cell CarcinomaMetastatic Triple-Negative Breast CarcinomaMetastatic Urothelial CarcinomaSkin Squamous Cell CarcinomaStage III Cervical Cancer AJCC v8Stage III Hepatocellular Carcinoma AJCC v8Stage III Lung Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Hepatocellular Carcinoma AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IVA Cervical Cancer AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Cervical Cancer AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IVB Lung Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8Triple-Negative Breast CarcinomaUnresectable Cervical CarcinomaUnresectable Endometrial CarcinomaUnresectable Gastric AdenocarcinomaUnresectable Gastroesophageal Junction AdenocarcinomaUnresectable Head and Neck Squamous Cell CarcinomaUnresectable Hepatocellular CarcinomaUnresectable Lung Non-Small Cell CarcinomaUnresectable Malignant Solid NeoplasmUnresectable MelanomaUnresectable Merkel Cell CarcinomaUnresectable Renal Cell CarcinomaUnresectable Skin Squamous Cell CarcinomaUnresectable Triple-Negative Breast CarcinomaUnresectable Urothelial CarcinomaBreast AdenocarcinomaStage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Invasive Breast Lobular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Willing to provide tissue specimens per protocol, or have clinically collected formalin-fixed paraffin-embedded (FFPE) tissue blocks, or available sequencing data available from commercial or research tests

NOTE 1: Includes fresh tissue specimen at pre-registration, or with or clinically collected FFPE tissue blocks for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo IRB protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and/or registration.

NOTE 2: This criteria will not apply to patients who had sequencing and neoantigen prediction previously completed.

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cyclophosphamide
  • Neoantigen Peptide Vaccine
  • Pembrolizumab
  • Sargramostim
  • Biospecimen Collection
  • Biopsy
  • Computed Tomography
  • Magnetic Resonance Imaging

Treatment groups

138 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov