Neoantigen Peptide Vaccine Plus Pembrolizumab in Renal Cell Carcinoma

NCT07686744 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PV-0001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, single-center, open-label, single-arm clinical trial to evaluate the safety and efficacy of personalized neoantigen polyepitope peptide vaccine combined with pembrolizumab in patients with advanced, recurrent or refractory renal cell carcinoma (RCC). Background: Renal cell carcinoma is one of the most common malignancies of the urinary system. Although pembrolizumab has become a standard first-line treatment, the objective response rate (ORR) of monotherapy is only 20-40%, and most patients eventually develop primary or acquired resistance. Tumor neoantigens are specific antigens produced by tumor-specific gene mutations, with high immunogenicity and tumor specificity, making them ideal targets for tumor immunotherapy. Preliminary clinical studies have shown that neoantigen vaccines can produce synergistic effects when combined with pembrolizumab. Study Design: This is an investigator-initiated trial (IIT) conducted at Peking University First Hospital. The study will enroll 5-8 patients in two stages: an initial safety assessment cohort (3 patients) followed by an expansion cohort (5 additional patients) if safety criteria are met. The study drug is a personalized neoantigen polyepitope peptide vaccine (Neo-RCC), produced by Mingzhibenyuan Medical Technology (Beijing) Co., Ltd., based on whole exome sequencing (WES) and transcriptome sequencing (RNA-seq) of each patient's tumor tissue. The vaccine is administered via subcutaneous injection in combination with Polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (Poly-ICLC) adjuvant, with a priming phase (5 injections on Days 0, 3, 7, 14, 21) and a boosting phase (3 injections on Weeks 6, 12, and 20), totaling 8 injections. Pembrolizumab (200 mg intravenous \[IV\] every 3 weeks \[Q3W\]) is administered concurrently as combination therapy. Primary Objective: To evaluate the safety of the personalized neoantigen peptide vaccine in advanced RCC patients, as measured by the incidence and severity of treatment-emergent adverse events (TEAE) graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Secondary Objectives: To evaluate pharmacokinetic characteristics; to assess efficacy including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key Eligibility Criteria: Adults (≥18 years) with Stage III or IV, locally advanced, recurrent or metastatic non-surgical RCC who have achieved disease stability for ≥3 months after prior targeted therapy combined with pembrolizumab; measurable disease per RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status 0-3; adequate organ function; and ≥50 tumor gene mutations detectable from biopsy tissue. Safety Monitoring: A Data Safety Monitoring Board (DSMB) will oversee patient safety. Dose-limiting toxicities (DLT) are defined according to protocol-specified criteria. If ≥2 DLTs occur in the initial cohort, the adjuvant dose will be reduced by 50% and the study will proceed with a de-escalation cohort.

Conditions

Advanced; Recurrent; Renal Cell Carcinoma; Refractory

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAE)

  The primary safety endpoint is the incidence and severity of treatment-emergent adverse events (TEAE), graded according to NCI CTCAE v5.0. TEAE is defined as any adverse event that occurs from the first administration of the study drug through 30 days after the last dose, or before initiation of new anti-tumor therapy, whichever occurs first. Key assessments include: (1) overall TEAE incidence rate; (2) Grade ≥3 TEAE incidence rate; (3) serious adverse event (SAE) incidence rate; (4) adverse events of special interest (AESI) including immune-related adverse events (irAEs), injection-site reactions, and cytokine release syndrome; (5) TEAE leading to dose modification, interruption, or permanent discontinuation; (6) treatment-related death. Safety monitoring covers the screening period, treatment period (8 vaccine injections over \~20 weeks plus concurrent pembrolizumab), and follow-up period.

  From first dose of study drug through 30 days after last dose, approximately 24 weeks

Secondary Outcomes (10)

• Objective Response Rate (ORR) per RECIST v1.1

  From first dose through disease progression or death, up to 2 years

• Duration of Response (DOR) per RECIST v1.1

  From first documented response to disease progression or death, up to 2 years

• Disease Control Rate (DCR) per RECIST v1.1

  From first dose through 6 weeks after first dose, up to 2 years

• Progression-Free Survival (PFS) per RECIST v1.1

  From first dose to disease progression or death, up to 2 years

• Overall Survival (OS)

  From first dose to death or last contact, up to 2 years

Study Arms (1)

Neo-RCC + Pembrolizumab

EXPERIMENTAL

All enrolled patients receive the same experimental intervention: personalized neoantigen polyepitope peptide vaccine (Neo-RCC) combined with pembrolizumab. The neoantigen vaccine is individually designed based on whole exome sequencing (WES) and RNA sequencing of each patient's tumor tissue, synthesized as 10-30 peptides (300 μg each), mixed with Poly-ICLC adjuvant, and administered via subcutaneous injection at 4 sites (bilateral axilla and groin) over 8 injections (priming on Days 0, 3, 7, 14, 21; boosting on Weeks 6, 12, 20). Pembrolizumab 200 mg IV is administered every 3 weeks concurrently. Enrollment follows a two-stage design: initial safety cohort (n=3) followed by expansion cohort (n=5) if dose-limiting toxicity criteria are met.

Drug: Personalized Neoantigen Polyepitope Peptide Vaccine

Interventions

Personalized Neoantigen Polyepitope Peptide Vaccine DRUG

This intervention consists of a personalized neoantigen polyepitope peptide vaccine (Neo-RCC) individually designed and manufactured for each patient based on whole exome sequencing (WES) and transcriptome sequencing (RNA-seq) of tumor tissue. The vaccine contains 10-30 synthetic long peptides (300 μg each) predicted to bind to the patient's Human Leukocyte Antigen(HLA), mixed with Poly-ICLC adjuvant (0.5 mg per pool). The total peptide dose is 4-9 mg per patient. Administration is via subcutaneous injection at 4 anatomical sites (bilateral axilla and bilateral groin) in 250 μL per site. The vaccination schedule includes a priming phase (5 injections on Days 0, 3, 7, 14, 21) and a boosting phase (3 injections on Weeks 6, 12, and 20), totaling 8 injections over approximately 20 weeks. The vaccine is administered in combination with pembrolizumab 200 mg intravenously every 3 weeks. Manufacturing is conducted under GMP conditions by Mingzhibenyuan Medical Technology (Beijing) Co., Ltd.

Also known as: Neo-RCC

Neo-RCC + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed Stage III or IV, locally advanced, recurrent or metastatic renal cell carcinoma (RCC) not amenable to curative surgery
• Disease stability for ≥3 months after prior single pembrolizumab therapy, with documented progression or intolerance to standard treatment
• 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)
• Age ≥18 years
• Estimated life expectancy ≥3 months
• ECOG performance status 0-3
• Availability of tumor tissue (biopsy or archival specimen) for whole exome sequencing (WES) and RNA sequencing (RNA-seq), with ≥50 tumor gene mutations detectable
• Adequate organ function as defined by laboratory parameters within 14 days prior to enrollment:
• 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;
• Ability to comply with study procedures and follow-up schedule;
• Signed informed consent form;
• 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;
• For men: agreement to use effective contraception during study and for 4 weeks after last dose.

You may not qualify if:

• Pregnant or lactating women
• Prior treatment with:
• 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;
• Active autoimmune disease or other immune-mediated disorders requiring systemic immunosuppressive therapy;
• Participation in another investigational drug study within 4 weeks prior to first dose;
• Active infection including:
• 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;
• Symptomatic central nervous system (CNS) metastases; exception: patients with treated CNS metastases stable for ≥4 weeks without neurological symptoms and without corticosteroid requirement;
• Uncontrolled comorbidities including:
• 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;
• Other malignancy within 5 years (except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin carcinoma);
• Live vaccine administration within 4 weeks prior to enrollment or planned during study (inactivated vaccines allowed);
• Known hypersensitivity to peptide vaccine components, adjuvants (e.g., Montanide ISA-51, Poly-ICLC), or pembrolizumab;
• Sarcomatoid or rhabdoid RCC as predominant histology (mixed histology allowed if non-pure sarcomatoid/rhabdoid);
• Any condition that, in the investigator's opinion, would compromise patient safety or compliance;

Sponsors & Collaborators

• Jian Lin: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (16)

• Plimack ER, Powles T, Stus V, Gafanov R, Nosov D, Waddell T, Alekseev B, Pouliot F, Melichar B, Soulieres D, Borchiellini D, McDermott RS, Vynnychenko I, Chang YH, Tamada S, Atkins MB, Li C, Perini R, Molife LR, Bedke J, Rini BI. Pembrolizumab Plus Axitinib Versus Sunitinib as First-line Treatment of Advanced Renal Cell Carcinoma: 43-month Follow-up of the Phase 3 KEYNOTE-426 Study. Eur Urol. 2023 Nov;84(5):449-454. doi: 10.1016/j.eururo.2023.06.006. Epub 2023 Jul 25.

  PMID: 37500340 BACKGROUND

• Tannir NM, Albiges L, McDermott DF, Burotto M, Choueiri TK, Hammers HJ, Barthelemy P, Plimack ER, Porta C, George S, Donskov F, Atkins MB, Gurney H, Kollmannsberger CK, Grimm MO, Barrios C, Tomita Y, Castellano D, Grunwald V, Rini BI, Jiang R, Desilva H, Fedorov V, Lee CW, Motzer RJ. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial. Ann Oncol. 2024 Nov;35(11):1026-1038. doi: 10.1016/j.annonc.2024.07.727. Epub 2024 Aug 2.

  PMID: 39098455 BACKGROUND

• Motzer RJ, Escudier B, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Plimack ER, Procopio G, McDermott DF, Castellano D, Choueiri TK, Donskov F, Gurney H, Oudard S, Richardet M, Peltola K, Alva AS, Carducci M, Wagstaff J, Chevreau C, Fukasawa S, Tomita Y, Gauler TC, Kollmannsberger CK, Schutz FA, Larkin J, Cella D, McHenry MB, Saggi SS, Tannir NM. Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial. Cancer. 2020 Sep 15;126(18):4156-4167. doi: 10.1002/cncr.33033. Epub 2020 Jul 16.

  PMID: 32673417 BACKGROUND

• Ott PA, Hu-Lieskovan S, Chmielowski B, Govindan R, Naing A, Bhardwaj N, Margolin K, Awad MM, Hellmann MD, Lin JJ, Friedlander T, Bushway ME, Balogh KN, Sciuto TE, Kohler V, Turnbull SJ, Besada R, Curran RR, Trapp B, Scherer J, Poran A, Harjanto D, Barthelme D, Ting YS, Dong JZ, Ware Y, Huang Y, Huang Z, Wanamaker A, Cleary LD, Moles MA, Manson K, Greshock J, Khondker ZS, Fritsch E, Rooney MS, DeMario M, Gaynor RB, Srinivasan L. A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Cell. 2020 Oct 15;183(2):347-362.e24. doi: 10.1016/j.cell.2020.08.053.

  PMID: 33064988 BACKGROUND

• Hu Z, Leet DE, Allesoe RL, Oliveira G, Li S, Luoma AM, Liu J, Forman J, Huang T, Iorgulescu JB, Holden R, Sarkizova S, Gohil SH, Redd RA, Sun J, Elagina L, Giobbie-Hurder A, Zhang W, Peter L, Ciantra Z, Rodig S, Olive O, Shetty K, Pyrdol J, Uduman M, Lee PC, Bachireddy P, Buchbinder EI, Yoon CH, Neuberg D, Pentelute BL, Hacohen N, Livak KJ, Shukla SA, Olsen LR, Barouch DH, Wucherpfennig KW, Fritsch EF, Keskin DB, Wu CJ, Ott PA. Personal neoantigen vaccines induce persistent memory T cell responses and epitope spreading in patients with melanoma. Nat Med. 2021 Mar;27(3):515-525. doi: 10.1038/s41591-020-01206-4. Epub 2021 Jan 21.

  PMID: 33479501 BACKGROUND

• Sahin U, Derhovanessian E, Miller M, Kloke BP, Simon P, Lower M, Bukur V, Tadmor AD, Luxemburger U, Schrors B, Omokoko T, Vormehr M, Albrecht C, Paruzynski A, Kuhn AN, Buck J, Heesch S, Schreeb KH, Muller F, Ortseifer I, Vogler I, Godehardt E, Attig S, Rae R, Breitkreuz A, Tolliver C, Suchan M, Martic G, Hohberger A, Sorn P, Diekmann J, Ciesla J, Waksmann O, Bruck AK, Witt M, Zillgen M, Rothermel A, Kasemann B, Langer D, Bolte S, Diken M, Kreiter S, Nemecek R, Gebhardt C, Grabbe S, Holler C, Utikal J, Huber C, Loquai C, Tureci O. Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer. Nature. 2017 Jul 13;547(7662):222-226. doi: 10.1038/nature23003. Epub 2017 Jul 5.

  PMID: 28678784 BACKGROUND

• Ott PA, Hu Z, Keskin DB, Shukla SA, Sun J, Bozym DJ, Zhang W, Luoma A, Giobbie-Hurder A, Peter L, Chen C, Olive O, Carter TA, Li S, Lieb DJ, Eisenhaure T, Gjini E, Stevens J, Lane WJ, Javeri I, Nellaiappan K, Salazar AM, Daley H, Seaman M, Buchbinder EI, Yoon CH, Harden M, Lennon N, Gabriel S, Rodig SJ, Barouch DH, Aster JC, Getz G, Wucherpfennig K, Neuberg D, Ritz J, Lander ES, Fritsch EF, Hacohen N, Wu CJ. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature. 2017 Jul 13;547(7662):217-221. doi: 10.1038/nature22991. Epub 2017 Jul 5.

  PMID: 28678778 BACKGROUND

• Wells DK, van Buuren MM, Dang KK, Hubbard-Lucey VM, Sheehan KCF, Campbell KM, Lamb A, Ward JP, Sidney J, Blazquez AB, Rech AJ, Zaretsky JM, Comin-Anduix B, Ng AHC, Chour W, Yu TV, Rizvi H, Chen JM, Manning P, Steiner GM, Doan XC; Tumor Neoantigen Selection Alliance; Merghoub T, Guinney J, Kolom A, Selinsky C, Ribas A, Hellmann MD, Hacohen N, Sette A, Heath JR, Bhardwaj N, Ramsdell F, Schreiber RD, Schumacher TN, Kvistborg P, Defranoux NA. Key Parameters of Tumor Epitope Immunogenicity Revealed Through a Consortium Approach Improve Neoantigen Prediction. Cell. 2020 Oct 29;183(3):818-834.e13. doi: 10.1016/j.cell.2020.09.015. Epub 2020 Oct 9.

  PMID: 33038342 BACKGROUND

• Bulik-Sullivan B, Busby J, Palmer CD, Davis MJ, Murphy T, Clark A, Busby M, Duke F, Yang A, Young L, Ojo NC, Caldwell K, Abhyankar J, Boucher T, Hart MG, Makarov V, Montpreville VT, Mercier O, Chan TA, Scagliotti G, Bironzo P, Novello S, Karachaliou N, Rosell R, Anderson I, Gabrail N, Hrom J, Limvarapuss C, Choquette K, Spira A, Rousseau R, Voong C, Rizvi NA, Fadel E, Frattini M, Jooss K, Skoberne M, Francis J, Yelensky R. Deep learning using tumor HLA peptide mass spectrometry datasets improves neoantigen identification. Nat Biotechnol. 2018 Dec 17. doi: 10.1038/nbt.4313. Online ahead of print.

  PMID: 30556813 BACKGROUND

• Chowell D, Krishna S, Becker PD, Cocita C, Shu J, Tan X, Greenberg PD, Klavinskis LS, Blattman JN, Anderson KS. TCR contact residue hydrophobicity is a hallmark of immunogenic CD8+ T cell epitopes. Proc Natl Acad Sci U S A. 2015 Apr 7;112(14):E1754-62. doi: 10.1073/pnas.1500973112. Epub 2015 Mar 23.

  PMID: 25831525 BACKGROUND

• Balachandran VP, Luksza M, Zhao JN, Makarov V, Moral JA, Remark R, Herbst B, Askan G, Bhanot U, Senbabaoglu Y, Wells DK, Cary CIO, Grbovic-Huezo O, Attiyeh M, Medina B, Zhang J, Loo J, Saglimbeni J, Abu-Akeel M, Zappasodi R, Riaz N, Smoragiewicz M, Kelley ZL, Basturk O; Australian Pancreatic Cancer Genome Initiative; Garvan Institute of Medical Research; Prince of Wales Hospital; Royal North Shore Hospital; University of Glasgow; St Vincent's Hospital; QIMR Berghofer Medical Research Institute; University of Melbourne, Centre for Cancer Research; University of Queensland, Institute for Molecular Bioscience; Bankstown Hospital; Liverpool Hospital; Royal Prince Alfred Hospital, Chris O'Brien Lifehouse; Westmead Hospital; Fremantle Hospital; St John of God Healthcare; Royal Adelaide Hospital; Flinders Medical Centre; Envoi Pathology; Princess Alexandria Hospital; Austin Hospital; Johns Hopkins Medical Institutes; ARC-Net Centre for Applied Research on Cancer; Gonen M, Levine AJ, Allen PJ, Fearon DT, Merad M, Gnjatic S, Iacobuzio-Donahue CA, Wolchok JD, DeMatteo RP, Chan TA, Greenbaum BD, Merghoub T, Leach SD. Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer. Nature. 2017 Nov 23;551(7681):512-516. doi: 10.1038/nature24462. Epub 2017 Nov 8.

  PMID: 29132146 BACKGROUND

• Duan F, Duitama J, Al Seesi S, Ayres CM, Corcelli SA, Pawashe AP, Blanchard T, McMahon D, Sidney J, Sette A, Baker BM, Mandoiu II, Srivastava PK. Genomic and bioinformatic profiling of mutational neoepitopes reveals new rules to predict anticancer immunogenicity. J Exp Med. 2014 Oct 20;211(11):2231-48. doi: 10.1084/jem.20141308. Epub 2014 Sep 22.

  PMID: 25245761 BACKGROUND

• Ghorani E, Rosenthal R, McGranahan N, Reading JL, Lynch M, Peggs KS, Swanton C, Quezada SA. Differential binding affinity of mutated peptides for MHC class I is a predictor of survival in advanced lung cancer and melanoma. Ann Oncol. 2018 Jan 1;29(1):271-279. doi: 10.1093/annonc/mdx687.

  PMID: 29361136 BACKGROUND

• Fritsch EF, Rajasagi M, Ott PA, Brusic V, Hacohen N, Wu CJ. HLA-binding properties of tumor neoepitopes in humans. Cancer Immunol Res. 2014 Jun;2(6):522-9. doi: 10.1158/2326-6066.CIR-13-0227. Epub 2014 Mar 3.

  PMID: 24894089 BACKGROUND

• Kim K, Kim HS, Kim JY, Jung H, Sun JM, Ahn JS, Ahn MJ, Park K, Lee SH, Choi JK. Predicting clinical benefit of immunotherapy by antigenic or functional mutations affecting tumour immunogenicity. Nat Commun. 2020 Feb 19;11(1):951. doi: 10.1038/s41467-020-14562-z.

  PMID: 32075964 BACKGROUND

• Yamamoto TN, Kishton RJ, Restifo NP. Developing neoantigen-targeted T cell-based treatments for solid tumors. Nat Med. 2019 Oct;25(10):1488-1499. doi: 10.1038/s41591-019-0596-y. Epub 2019 Oct 7.

  PMID: 31591590 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jian Lin, Professor

CONTACT

+86 1380-1358-465; linjianbj@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: This is a single-arm, open-label Phase I study with a two-stage enrollment design. All enrolled patients receive the same experimental intervention: personalized neoantigen polyepitope peptide vaccine (Neo-RCC) combined with pembrolizumab. The study includes an initial safety cohort (3 patients) followed by an expansion cohort (5 patients) if dose-limiting toxicity criteria are met. No randomization or control arm is employed.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: IPD and supporting information will be available to qualified researchers upon reasonable request. Interested researchers may contact the Principal Investigator or the study team at Peking University First Hospital to submit a data access request. The request should include a detailed research proposal outlining the scientific rationale, specific data requirements, and planned analyses. Access will be granted following review and approval by the study team, subject to compliance with applicable data protection regulations, patient confidentiality agreements, and institutional policies. De-identified individual participant data, along with the study protocol and statistical analysis plan, may be shared via a secure data transfer mechanism. Data access is contingent upon the execution of a data use agreement and is intended solely for non-commercial research purposes.

Locations

CN (1)