OncoMatch/Clinical Trials/NCT05098210
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer
Is NCT05098210 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Neoantigen Peptide Vaccine and Nivolumab for anatomic stage iv breast cancer ajcc v8.
Treatment: Neoantigen Peptide Vaccine · Nivolumab · Poly ICLC — This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment (refractory) or stage III-IV non-small cell lung cancer. Personalized neo-antigen peptide vaccine is a product that combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Melanoma
Non-Small Cell Lung Carcinoma
Tumor Agnostic
Biomarker criteria
Required: BRAF any tested
Known BRAF mutational status
Required: KRAS any tested
Genetic testing must have been performed for targetable driver mutations, including EGFR, ROS1, Alk, KRAS, BRAF
Excluded: EGFR activating mutation
Activating mutations in EGFR ... are associated with lower mutation burden and non-response to immune therapies
Excluded: ROS1 genetic alteration
genetic alterations in ROS1 ... are associated with lower mutation burden and non-response to immune therapies
Excluded: ALK genetic alteration
genetic alterations in ... Alk, as these mutations are associated with lower mutation burden and non-response to immune therapies
Disease stage
Required: Stage IIIC, IIID, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — metastatic or advanced
have persistent/recurrent disease after at least one line of therapy prior to enrollment on the study
Must have received: PD-1 or PD-L1 inhibitor — metastatic or advanced
History of detectable disease during/after treatment with a PD-1 or PD-L1 inhibitor
Cannot have received: allogeneic bone marrow transplantation
Prior allogeneic bone marrow transplantation
Cannot have received: solid organ transplantation
prior solid organ transplantation
Lab requirements
Blood counts
Absolute neutrophil count (ANC) > 1000 cells/mm^3; Hemoglobin >= 9 mg/dL; Platelet count >= 50,000/uL
Kidney function
Serum creatine < 1.5 mg/dL or estimated glomerular filtration rate (eGFR) > 60 mL/min
Liver function
Total bilirubin (tBili) < 1.5 x ULN and AST/ALT < 2.5 x ULN and < 5 x ULN for subjects with documented liver metastasis. Patients with suspected Gilbert syndrome may be included if tBili > 3 but no other evidence of hepatic dysfunction
Cardiac function
Patients 60 years of age or older: LVEF >= 50% by echocardiogram or MUGA scan within 60 days prior to enrollment. Cardiac evaluation for other patients is at the discretion of the treating physician
Serum creatine < 1.5 mg/dL or eGFR > 60 mL/min; tBili < 1.5 x ULN and AST/ALT < 2.5 x ULN and < 5 x ULN for subjects with documented liver metastasis; ANC > 1000 cells/mm^3; Hemoglobin >= 9 mg/dL; Platelet count >= 50,000/uL; LVEF >= 50% for patients >= 60 years
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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