Renal Cell CarcinomaPhase 1NPVPPNCT07686744
Neoantigen Peptide Vaccine Plus Pembrolizumab in Renal Cell Carcinoma
A Phase 1 study testing Personalized Neoantigen Polyepitope Peptide Vaccine in people with Renal Cell Carcinoma and Advanced, run by Jian Lin at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Advanced, Recurrent
- What is being tested?
- Personalized Neoantigen Polyepitope Peptide Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- 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;
- 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.
Who cannot join
- Pregnant or lactating women
- 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;
- 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:
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- 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;
- 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:
- 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;
- 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;
- Any other condition that the investigator considers unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yinmo Yang, Professor, +86-10-83572211, bdyyec@163.com
About this study
Official title: A Phase I Clinical Trial of Personalized Neoantigen Peptide Vaccine in Combination With Pembrolizumab for the Safety and Efficacy in Patients With Advanced, Recurrent or Refractory Renal Cell Carcinoma
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.
Read more
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.
Read the detailed description
Study Rationale: This study addresses the unmet need for effective second-line or later treatment options for advanced renal cell carcinoma (RCC) patients who have progressed or become refractory after initial immunotherapy. The combination strategy leverages the complementary mechanisms of personalized neoantigen vaccines (which activate tumor-specific T-cell responses) and pembrolizumab (which blocks programmed cell death protein 1 (PD-1)-mediated immune suppression), potentially overcoming PD-1 inhibitor resistance.
Neoantigen Prediction and Vaccine Manufacturing: Tumor tissue and peripheral blood samples are collected for whole exome sequencing (WES) and RNA sequencing (RNA-seq). A proprietary neoantigen prediction platform (neoTrue AI) analyzes sequencing data to identify tumor-specific mutations and predict neoantigen-major histocompatibility complex (MHC) binding affinity. The top 10-30 ranked neoantigen peptides are selected for Good Manufacturing Practice (GMP)-grade synthesis. The median manufacturing period is approximately 12 weeks. Each peptide is 300 μg, mixed with Polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (Poly-ICLC) adjuvant (0.5 mg per pool), and administered as 4 pools (left/right axilla and left/right groin) in 250 μL per injection site.
Pembrolizumab Administration: Pembrolizumab 200 mg is administered intravenously (IV) every 3 weeks (Q3W), diluted in 100 mL 0.9% sodium chloride over 30 minutes. Treatment continues for up to 2 years or until disease progression, unacceptable toxicity, or patient withdrawal. During the vaccine manufacturing period (~12 weeks), pembrolizumab may be continued as bridging therapy to maintain disease stability.
Dose-Limiting Toxicity (DLT) Definition: Hematologic: Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5×10⁹/L) lasting >7 days; Grade 4 thrombocytopenia (<25×10⁹/L) within 7 days. Non-hematologic: Grade 3 non-hematologic toxicity lasting >7 days (with specified exceptions); Grade 4 toxicity. Immune-related: ≥Grade 3 immune pneumonitis, colitis, hepatitis; any-grade myocarditis; ≥Grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) or immune encephalitis; ≥Grade 3 severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], drug reaction with eosinophilia and systemic symptoms [DRESS]). Other: ≥Grade 2 cytokine release syndrome (CRS) (per American Society for Transplantation and Cellular Therapy [ASTCT] criteria); ≥Grade 3 injection-site reactions requiring surgical intervention; ≥Grade 3 allergic reactions; ≥Grade 3 infections; ≥Grade 3 thromboembolic events; ≥Grade 3 bleeding.
DLT Management: If ≥2 DLTs occur in the first 3 patients during the first 8 weeks (D0-D56), the adjuvant total dose will be reduced by 50% (to 1.0 mg), and 2 additional patients will be enrolled in the de-escalation cohort. If ≥2 DLTs occur in the de-escalation cohort, the study will be terminated. If ≥3 DLTs occur in the expansion cohort, the regimen will be deemed to have unacceptable toxicity.
Efficacy Assessments: Tumor assessments by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 are conducted at screening, every 6-8 weeks during treatment, at treatment completion/early termination, and during follow-up. Blinded Independent Central Review (BICR) may be used as sensitivity analysis.
Pharmacokinetic/Immunogenicity Assessments: Peripheral blood mononuclear cells (PBMCs) are collected at baseline, 24-72 hours post-injection, every 2 treatment cycles, and at treatment completion. Neoantigen-specific T-cell responses are quantified by quantitative polymerase chain reaction (qPCR) for interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), interleukin-2 (IL-2), granzyme B, and perforin mRNA expression. T-cell receptor (TCR) sequencing is performed to track clonal expansion. Circulating tumor DNA minimal residual disease (ctDNA-MRD) monitoring panels are designed based on each patient's WES data and detected by targeted next-generation sequencing (NGS).
Follow-up Schedule: Long-term follow-up every 3 months for survival status and subsequent anti-tumor treatments.
Risk Mitigation: Comprehensive risk management plans are established for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune-related adverse events (irAEs), infections, injection-related reactions, adjuvant-related risks, pseudoprogression, hyperprogressive disease, and RCC-specific complications (paraneoplastic syndromes, hemorrhage, thromboembolism). A Data Safety Monitoring Board (DSMB) is constituted to oversee safety.
Funding: This study is supported by a research grant from the GenScript Life Science Research Grant Program (2024), with additional support from Mingzhibenyuan Medical Technology (Beijing) Co., Ltd. for neoantigen prediction and peptide synthesis.
- Conditions
- Renal Cell Carcinoma, Advanced, Recurrent, Refractory
- Being tested
- Personalized Neoantigen Polyepitope Peptide Vaccine
- Medical subject headings
- Carcinoma, Renal Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Neoantigen Polyepitope Peptide VaccineDrug
Also called Neo-RCC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Personalized Neoantigen Polyepitope Peptide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Objective Response Rate (ORR) is defined as the proportion of patients achieving best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria. Tumor assessments are conducted by CT or MRI at screening, every 6-8 weeks during treatment, at treatment completion/early termination, and during follow-up. Blinded Independent Central Review (BICR) may be used as sensitivity analysis. ORR reflects the anti-tumor activity of the personalized neoantigen polyepitope peptide vaccine combined with pembrolizumab in advanced RCC patients.
Measured: From first dose through disease progression or death, up to 2 years
Duration of Response (DOR) per RECIST v1.1
Duration of Response (DOR) is defined as the time from first documented CR or PR (whichever occurs first) to first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first. For patients who have not progressed or died at the time of analysis, DOR is censored at the last tumor assessment date.
Measured: From first documented response to disease progression or death, up to 2 years
Disease Control Rate (DCR) per RECIST v1.1
Disease Control Rate (DCR) is defined as the proportion of patients achieving best overall response of complete response(CR), partial response(PR), or stable disease (SD) with duration ≥6 weeks per RECIST v1.1 criteria.
Measured: From first dose through 6 weeks after first dose, up to 2 years
Progression-Free Survival (PFS) per RECIST v1.1
Progression-Free Survival (PFS) is defined as the time from first dose of study drug to first documented PD per RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not progressed or died are censored at the last tumor assessment date.
Measured: From first dose to disease progression or death, up to 2 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time from first dose of study drug to death from any cause. Patients who are alive at the time of analysis are censored at the last known alive date.
Measured: From first dose to death or last contact, up to 2 years
Cmax of neoantigen-specific T-cell response
Peak level of neoantigen-specific T-cell response in peripheral blood during treatment, measured by qPCR for IFN-γ, TNF-α, IL-2, granzyme B, perforin mRNA expression or TCR clonotype analysis. Peripheral blood mononuclear cells(PBMCs) collected at baseline, 24-72 hours post-injection, every 2 treatment cycles, and at treatment completion.
Measured: From first dose through 30 days after last dose, approximately 24 weeks
Tmax of neoantigen-specific T-cell response
Time from first dose to peak level (Cmax) of neoantigen-specific T-cell response in peripheral blood, measured by qPCR for IFN-γ, TNF-α, IL-2, granzyme B, perforin mRNA expression or TCR clonotype analysis. PBMCs collected at baseline, 24-72 hours post-injection, every 2 treatment cycles, and at treatment completion.
Measured: From first dose through 30 days after last dose, approximately 24 weeks
Duration of neoantigen-specific T-cell response
Time from first detectable neoantigen-specific T-cell response to return to baseline or below threshold, measured by qPCR for IFN-γ, TNF-α, IL-2, granzyme B, perforin mRNA expression or TCR clonotype analysis. PBMCs collected at baseline, 24-72 hours post-injection, every 2 treatment cycles, and at treatment completion.
Measured: From first dose through 30 days after last dose, approximately 24 weeks
Area under curve(AUC) of neoantigen-specific T-cell response
Area under the T-cell response-time curve for neoantigen-specific immune response in peripheral blood, measured by qPCR for IFN-γ, TNF-α, IL-2, granzyme B, perforin mRNA expression or TCR clonotype analysis. PBMCs collected at baseline, 24-72 hours post-injection, every 2 treatment cycles, and at treatment completion.
Measured: From first dose through 30 days after last dose, approximately 24 weeks
Percent change from baseline in neoantigen-specific T-cell response
Percent change from baseline at each timepoint for neoantigen-specific T-cell response in peripheral blood, measured by qPCR for IFN-γ, TNF-α, IL-2, granzyme B, perforin mRNA expression or TCR clonotype analysis. PBMCs collected at baseline, 24-72 hours post-injection, every 2 treatment cycles, and at treatment completion.
Measured: From first dose through 30 days after last dose, approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Lin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686744
- Sponsor's protocol ID
- PV-0001
- Acronym
- NPVPP
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37500340Tannir 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.
PubMed 39098455Motzer 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.
PubMed 32673417Ott 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.
PubMed 33064988Hu 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.
PubMed 33479501Sahin 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.
PubMed 28678784Ott 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.
PubMed 28678778Wells 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.
PubMed 33038342Bulik-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.
PubMed 30556813Chowell 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.
PubMed 25831525Balachandran 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.
PubMed 29132146Duan 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.
PubMed 25245761Ghorani 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.
PubMed 29361136Fritsch 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.
PubMed 24894089Kim 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.
PubMed 32075964
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Personalized Neoantigen Peptide Vaccine in Combination With Pembrolizumab for the Safety and Efficacy in Patients With Advanced, Recurrent or Refractory Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07686744
- Acronym / sponsor ID
- NPVPP / PV-0001
- Conditions
- Renal Cell Carcinoma, Advanced, Recurrent, Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Jian LinUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Rationale: This study addresses the unmet need for effective second-line or later treatment options for advanced renal cell carcinoma (RCC) patients who have progressed or become refractory after initial immunotherapy. The combination strategy leverages the complementary mechanisms of personalized neoantigen vaccines (which activate tumor-specific T-cell responses) and pembrolizumab (which blocks programmed cell death protein 1 (PD-1)-mediated immune suppression), potentially overcoming PD-1 inhibitor resistance.
Neoantigen Prediction and Vaccine Manufacturing: Tumor tissue and peripheral blood samples are collected for whole exome sequencing (WES) and RNA sequencing (RNA-seq). A proprietary neoantigen prediction platform (neoTrue AI) analyzes sequencing data to identify tumor-specific mutations and predict neoantigen-major histocompatibility complex (MHC) binding affinity. The top 10-30 ranked neoantigen peptides are selected for Good Manufacturing Practice (GMP)-grade synthesis. The median manufacturing period is approximately 12 weeks. Each peptide is 300 μg, mixed with Polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (Poly-ICLC) adjuvant (0.5 mg per pool), and administered as 4 pools (left/right axilla and left/right groin) in 250 μL per injection site.
Pembrolizumab Administration: Pembrolizumab 200 mg is administered intravenously (IV) every 3 weeks (Q3W), diluted in 100 mL 0.9% sodium chloride over 30 minutes. Treatment continues for up to 2 years or until disease progression, unacceptable toxicity, or patient withdrawal. During the vaccine manufacturing period (~12 weeks), pembrolizumab may be continued as bridging therapy to maintain disease stability.
Dose-Limiting Toxicity (DLT) Definition: Hematologic: Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5×10⁹/L) lasting >7 days; Grade 4 thrombocytopenia (<25×10⁹/L) within 7 days. Non-hematologic: Grade 3 non-hematologic toxicity lasting >7 days (with specified exceptions); Grade 4 toxicity. Immune-related: ≥Grade 3 immune pneumonitis, colitis, hepatitis; any-grade myocarditis; ≥Grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) or immune encephalitis; ≥Grade 3 severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], drug reaction with eosinophilia and systemic symptoms [DRESS]). Other: ≥Grade 2 cytokine release syndrome (CRS) (per American Society for Transplantation and Cellular Therapy [ASTCT] criteria); ≥Grade 3 injection-site reactions requiring surgical intervention; ≥Grade 3 allergic reactions; ≥Grade 3 infections; ≥Grade 3 thromboembolic events; ≥Grade 3 bleeding.
DLT Management: If ≥2 DLTs occur in the first 3 patients during the first 8 weeks (D0-D56), the adjuvant total dose will be reduced by 50% (to 1.0 mg), and 2 additional patients will be enrolled in the de-escalation cohort. If ≥2 DLTs occur in the de-escalation cohort, the study will be terminated. If ≥3 DLTs occur in the expansion cohort, the regimen will be deemed to have unacceptable toxicity.
Efficacy Assessments: Tumor assessments by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 are conducted at screening, every 6-8 weeks during treatment, at treatment completion/early termination, and during follow-up. Blinded Independent Central Review (BICR) may be used as sensitivity analysis.
Pharmacokinetic/Immunogenicity Assessments: Peripheral blood mononuclear cells (PBMCs) are collected at baseline, 24-72 hours post-injection, every 2 treatment cycles, and at treatment completion. Neoantigen-specific T-cell responses are quantified by quantitative polymerase chain reaction (qPCR) for interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), interleukin-2 (IL-2), granzyme B, and perforin mRNA expression. T-cell receptor (TCR) sequencing is performed to track clonal expansion. Circulating tumor DNA minimal residual disease (ctDNA-MRD) monitoring panels are designed based on each patient's WES data and detected by targeted next-generation sequencing (NGS).
Follow-up Schedule: Long-term follow-up every 3 months for survival status and subsequent anti-tumor treatments.
Risk Mitigation: Comprehensive risk management plans are established for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune-related adverse events (irAEs), infections, injection-related reactions, adjuvant-related risks, pseudoprogression, hyperprogressive disease, and RCC-specific complications (paraneoplastic syndromes, hemorrhage, thromboembolism). A Data Safety Monitoring Board (DSMB) is constituted to oversee safety.
Funding: This study is supported by a research grant from the GenScript Life Science Research Grant Program (2024), with additional support from Mingzhibenyuan Medical Technology (Beijing) Co., Ltd. for neoantigen prediction and peptide synthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neo-RCC + Pembrolizumab | Experimental | Drug: Personalized Neoantigen Polyepitope Peptide VaccineAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- Pregnant or lactating women
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Neoantigen Polyepitope Peptide VaccineAlso: Neo-RCCThis 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. | Drug | Neo-RCC + Pembrolizumab |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAE)
Time frame: From first dose of study drug through 30 days after last dose, approximately 24 weeks
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.
10 secondary outcomes
Objective Response Rate (ORR) per RECIST v1.1
Time frame: From first dose through disease progression or death, up to 2 years
Duration of Response (DOR) per RECIST v1.1
Time frame: From first documented response to disease progression or death, up to 2 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: From first dose through 6 weeks after first dose, up to 2 years
Progression-Free Survival (PFS) per RECIST v1.1
Time frame: From first dose to disease progression or death, up to 2 years
Overall Survival (OS)
Time frame: From first dose to death or last contact, up to 2 years
Cmax of neoantigen-specific T-cell response
Time frame: From first dose through 30 days after last dose, approximately 24 weeks
Tmax of neoantigen-specific T-cell response
Time frame: From first dose through 30 days after last dose, approximately 24 weeks
Duration of neoantigen-specific T-cell response
Time frame: From first dose through 30 days after last dose, approximately 24 weeks
Area under curve(AUC) of neoantigen-specific T-cell response
Time frame: From first dose through 30 days after last dose, approximately 24 weeks
Percent change from baseline in neoantigen-specific T-cell response
Time frame: From first dose through 30 days after last dose, approximately 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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- Background: PubMed 32673417Motzer 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.
- Background: PubMed 33064988Ott 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.
- Background: PubMed 33479501Hu 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.
- Background: PubMed 28678784Sahin 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.
- Background: PubMed 28678778Ott 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.
- Background: PubMed 33038342Wells 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.
- Background: PubMed 30556813Bulik-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.
- Background: PubMed 25831525Chowell 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.
- Background: PubMed 29132146Balachandran 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.
- Background: PubMed 25245761Duan 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Personalized Neoantigen Polyepitope Peptide Vaccine in people with Renal Cell Carcinoma and Advanced, run by Jian Lin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Lin, Professor (+86 1380-1358-465, linjianbj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAE) (time frame: From first dose of study drug through 30 days after last dose, approximately 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07686744, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.