Recruiting PHASE1/PHASE2 INTERVENTIONAL 4-arm NCT05269381

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

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

Sponsor: Mayo Clinic

Conditions 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 Breast Adenocarcinoma 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 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage III Hepatocellular Carcinoma AJCC v8 Stage III Lung Cancer AJCC v8 Stage III Renal Cell Cancer AJCC v8 Stage III Uterine Corpus Carcinoma or Carcinosarcoma 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 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Stage IV Uterine Corpus Carcinoma or Carcinosarcoma 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

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

Updated 10 times since 2022 Last updated: Mar 10, 2026 Started: Mar 31, 2022 Primary completion: Mar 31, 2028 Completion: Mar 31, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8, this trial is actively recruiting participants. The trial is conducted by Mayo Clinic and has accumulated 10 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

10 versions recorded

Mar 2026 — Present [monthly]

Recruiting PHASE1/PHASE2
Sep 2024 — Mar 2026 [monthly]

Recruiting PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1/PHASE2

Phase: PHASE1 → PHASE1/PHASE2
Feb 2024 — Jul 2024 [monthly]

Recruiting PHASE1
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE1

▶ Show 5 earlier versions

Aug 2023 — Jan 2024 [monthly]

Recruiting PHASE1
Jun 2023 — Aug 2023 [monthly]

Recruiting PHASE1
Feb 2023 — Jun 2023 [monthly]

Recruiting PHASE1
May 2022 — Feb 2023 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Apr 2022 — May 2022 [monthly]

Not Yet Recruiting PHASE1

First recorded

Mar 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Mayo Clinic

Data source: Mayo Clinic

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Jacksonville, United States