OncoMatch/Clinical Trials/NCT05269381
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
Is NCT05269381 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Neoantigen Peptide Vaccine and Pembrolizumab for anatomic stage iii breast cancer ajcc v8.
Treatment: Cyclophosphamide · Neoantigen Peptide Vaccine · Pembrolizumab · Sargramostim — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Melanoma
Gastric Cancer
Esophageal Carcinoma
Tumor Agnostic
Cervical Cancer
Endometrial Cancer
Head and Neck Squamous Cell Carcinoma
Hepatocellular Carcinoma
Non-Small Cell Lung Carcinoma
Renal Cell Carcinoma
Triple-Negative Breast Cancer
Urothelial Carcinoma
Biomarker criteria
Required: EGFR wild-type
No actionable EGFR mutations and ALK fusions [Cohort 4 NSCLC]
Required: ALK wild-type
No actionable EGFR mutations and ALK fusions [Cohort 4 NSCLC]
Allowed: EGFR actionable mutation
Patients with actionable genomic abnormality including, but not limited to EGFR... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: ALK fusion
Patients with actionable genomic abnormality including, but not limited to... ALK... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: MET actionable abnormality
Patients with actionable genomic abnormality including, but not limited to... MET... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: ROS1 fusion
Patients with actionable genomic abnormality including, but not limited to... ROS-1... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: RET fusion
Patients with actionable genomic abnormality including, but not limited to... RET... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: NTRK1 fusion
Patients with actionable genomic abnormality including, but not limited to... NTRK... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: NTRK2 fusion
Patients with actionable genomic abnormality including, but not limited to... NTRK... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: NTRK3 fusion
Patients with actionable genomic abnormality including, but not limited to... NTRK... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: KRAS actionable mutation
Patients with actionable genomic abnormality including, but not limited to... KRAS... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: BRAF actionable mutation
Patients with actionable genomic abnormality including, but not limited to... BRAF... must have received and progressed on at least one line of prior FDA-approved targeted therapy
Disease stage
Required: Stage I, II, III, IV (AJCC 7th (TNBC), AJCC 8th (NSCLC))
Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC) [TNBC]; Stage II or stage III based on AJCC 8th [NSCLC]; Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease [Phase I/II]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: GM-CSF
Any prior hypersensitivity or adverse reaction to GM-CSF
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1500/mm³; Platelet count ≥ 100,000/mm³
Kidney function
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 50 ml/min using Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 3 x ULN or ≤ 5 x ULN with liver metastases
Hemoglobin >= 9.0 g/dL; Absolute neutrophil count (ANC) >= 1500/mm^3; Platelet count >= 100,000/mm^3; Total bilirubin =< 1.5 x upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN or =< 5 x ULN with liver metastases; Creatinine =< 1.5 x ULN OR calculated creatinine clearance must be >= 50 ml/min using Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
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