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NCT05269381 · ClinicalTrials.gov record · last posted 2026-08-20

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

Study acronym: PNeoVCA
StatusRecruiting
PhasePhase 1/2
Started2022-03-31
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-21
Primary endpoint(s) modified
WasDisease-free survival (DFS) (Phase II Cohort 4), Dose LImiting Toxicity (DLT) (Phase I), Event free survival (EFS) (Phase II Cohort 3), Incidence of adverse events (Phase I), Maximally tolerated dose (MTD) (Phase I)
NowDisease-free survival (DFS) (Phase II Cohort 4), Dose Limiting Toxicity (DLT) (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5), Event free survival (EFS) (Phase II Cohort 3), Incidence of adverse events (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5), Maximally tolerated dose (MTD) (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5)
2026-08-21
Trial arms changed: 4 → 5
Trial Details
NCT Number NCT05269381
Lead 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, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 +93 more
Enrollment 138 participants
Start Date 2022-03-31
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20