Custom-Made vaccine aims to boost immune attack on kidney tumors

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or cytologically confirmed Stage III or IV, locally advanced, recurrent or metastatic renal cell carcinoma (RCC) not amenable to curative surgery 2. Disease stability for ≥3 months after prior single pembrolizumab therapy, with documented progression or intolerance to standard treatment 3. At least one measurable lesion per RECIST v1.1 (longest diameter ≥10 mm for non-lymph node lesions; short axis ≥15 mm for lymph nodes; or bone lesions confirmed by CT/MRI) 4. Age ≥18 years 5. Estimated life expectancy ≥3 months 6. ECOG performance status 0-3 7. Availability of tumor tissue (biopsy or archival specimen) for whole exome sequencing (WES) and RNA sequencing (RNA-seq), with ≥50 tumor gene mutations detectable 8. Adequate organ function as defined by laboratory parameters within 14 days prior to enrollment: 8.1 Hematologic: Absolute Neutrophil Count(ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; 8.2 Hepatic: total bilirubin(TBIL) ≤1.5×Upper Limit of Normal(ULN), Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT) ≤2.5×ULN (≤5×ULN if liver metastases present); 8.3 Renal: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); 8.4 Coagulation: international normalized ratio(INR) ≤1.5, activated partial thromboplastin time(APTT) ≤1.5×ULN; 8.5 Cardiac: Left Ventricular Ejection Fractions(LVEF) ≥50% by echocardiography; 9. Ability to comply with study procedures and follow-up schedule; 10. Signed informed consent form; 11. For women of childbearing potential: negative serum pregnancy test (Human Chorionic Gonadotropin sensitivity ≤25 IU/L) within 7 days prior to enrollment; agreement to use effective contraception during study and for 4 weeks after last dose; 12. For men: agreement to use effective contraception during study and for 4 weeks after last dose. Exclusion Criteria: 1. Pregnant or lactating women 2. Prior treatment with: 2.1 Two or more lines of immune checkpoint inhibitor (ICI) systemic therapy; 2.2 CTLA-4 inhibitor (e.g., ipilimumab); 2.3 Tumor vaccine therapy (including neoantigen vaccine, dendritic cell vaccine, etc.); 2.4 Chemotherapy specifically for renal cell carcinoma; 2.5 Allogeneic hematopoietic stem cell or solid organ transplantation; 3. Active autoimmune disease or other immune-mediated disorders requiring systemic immunosuppressive therapy; 4. Participation in another investigational drug study within 4 weeks prior to first dose; 5. Active infection including: 5.1 Known Human Immunodeficiency Virus(HIV) infection; 5.2 Active hepatitis B (HBsAg positive and Hepatitis B Virus-DNA \>500 IU/mL) or hepatitis C (HCV-RNA positive); 5.3 Active tuberculosis (T-SPOT or PPD positive with clinical symptoms, or chest CT suggestive of active TB); 5.4 Severe infection requiring intravenous antibiotics within 2 weeks prior to enrollment, or uncontrolled systemic infection; 6. Symptomatic central nervous system (CNS) metastases; exception: patients with treated CNS metastases stable for ≥4 weeks without neurological symptoms and without corticosteroid requirement; 7. Uncontrolled comorbidities including: 7.1 Symptomatic congestive heart failure (New York Heart Association Class III-IV); 7.2 Unstable angina or myocardial infarction within 6 months; 7.3 Uncontrolled arrhythmia; 7.4 Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg despite standard treatment); 7.5 Active peptic ulcer or gastrointestinal bleeding; 7.6 Active interstitial lung disease or pulmonary fibrosis; 8. Other malignancy within 5 years (except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin carcinoma); 9. Live vaccine administration within 4 weeks prior to enrollment or planned during study (inactivated vaccines allowed); 10. Known hypersensitivity to peptide vaccine components, adjuvants (e.g., Montanide ISA-51, Poly-ICLC), or pembrolizumab; 11. Sarcomatoid or rhabdoid RCC as predominant histology (mixed histology allowed if non-pure sarcomatoid/rhabdoid); 12. Any condition that, in the investigator's opinion, would compromise patient safety or compliance; 13. Any other condition that the investigator considers unsuitable for study participation.