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

> **NCT05269381** · PHASE1,PHASE2 · RECRUITING · sponsor: **Mayo Clinic** · enrollment: 132 (estimated)

## 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

## Interventions

- **DRUG:** Cyclophosphamide
- **BIOLOGICAL:** Neoantigen Peptide Vaccine
- **BIOLOGICAL:** Pembrolizumab
- **BIOLOGICAL:** Sargramostim
- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Biopsy
- **PROCEDURE:** Computed Tomography
- **PROCEDURE:** Magnetic Resonance Imaging

## Key facts

- **NCT ID:** NCT05269381
- **Lead sponsor:** Mayo Clinic
- **Sponsor class:** OTHER
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2022-03-31
- **Primary completion:** 2028-03-31
- **Final completion:** 2028-03-31
- **Target enrollment:** 132 (ESTIMATED)
- **Last updated:** 2026-03-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05269381

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05269381, "Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors". Retrieved via AI Analytics 2026-06-15 from https://api.ai-analytics.org/clinical/NCT05269381. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*