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 (Sep 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
Treatments studied
Immunotherapy
Chemotherapy
Other
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
Allowed: EGFR actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: ALK actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: MET actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: ROS1 actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: RET actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: NTRK1 actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: NTRK2 actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: NTRK3 actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: KRAS actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Allowed: BRAF actionable genomic abnormality
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Disease stage
Required: Stage III, IIIA, IIIB, IIIC, IV, IVA, IVB, II, I (other)
Stage III/IV and locally advanced solid tumors per protocol
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: targeted therapy — for actionable genomic abnormality (EGFR, ALK, MET, ROS1, RET, NTRK, KRAS, BRAF)
Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3
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 (≤ 5 x ULN with liver involvement)
Lab values as per protocol: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3; Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 3 x ULN (≤ 5 x ULN with liver involvement); Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 50 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05269381 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received targeted therapy.
What disease stage is eligible?
Stage III or IIIA or IIIB or IIIC or IV or IVA or IVB or II or I is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages