{"entity":{"id":"nct05269381","kind":"trial","name":"Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","aka":["PNeoVCA"],"tldr":"A phase 1/2 trial of cyclophosphamide, pembrolizumab and sargramostim in triple-negative breast cancer, run by Mayo Clinic, now recruiting.","summary":"Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors is a phase 1/2, interventional study registered as NCT05269381 by Mayo Clinic, with a registry enrolment figure of 138 participants, started 2022-03-31 and due to reach its primary completion in 2028-03-31. Interventions recorded: Cyclophosphamide; Neoantigen Peptide Vaccine; Pembrolizumab; Sargramostim; Biospecimen Collection; Biopsy; Computed Tomography; Magnetic Resonance Imaging. Conditions listed: 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; Invasive Breast Lobular Carcinoma. Triple-negative eligibility wording from the registry: \"PHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05269381","url":"https://clinicaltrials.gov/study/NCT05269381"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-early","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide","pembrolizumab","sargramostim"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05269381","phase":"1/2","setting":"A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","sponsor":"Mayo Clinic","enrolled":138,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05269381/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"sargramostim","kind":"drug","name":"Sargramostim","route":"/drugs/sargramostim/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}]}}