RecruitingPhase 1Phase 2NCT05269381

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

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)


Sponsor

Mayo Clinic

Enrollment

132 participants

Start Date

Mar 31, 2022

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Metastatic Triple-Negative Breast CarcinomaBreast AdenocarcinomaUnresectable Triple-Negative Breast CarcinomaAnatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC 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 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 Urothelial CarcinomaStage 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 v8

Summary

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

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized cancer vaccine made from your tumor's unique mutations (neoantigens), combined with the immunotherapy drug pembrolizumab, for people with advanced solid tumors. **You may be eligible if...** - You have an advanced solid tumor with measurable disease - You are willing to provide a fresh tumor biopsy for genetic analysis - If your tumor has a known targetable mutation (e.g., EGFR, ALK, KRAS, BRAF), you must have already tried and progressed on at least one approved targeted therapy - You are able to return to the enrolling institution for follow-up visits **You may NOT be eligible if...** - You have a tumor lesion only in a previously irradiated area (not considered measurable) - You are unable or unwilling to provide tissue samples - You have certain serious health conditions that would prevent you from safely participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Given IV

BIOLOGICALNeoantigen Peptide Vaccine

Receive personalized neoantigen vaccine SC

BIOLOGICALPembrolizumab

Given IV

BIOLOGICALSargramostim

Given SC

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBiopsy

Undergo tissue biopsy

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT05269381


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