AzTrials
AzTrials

Advanced Malignant Solid TumorPhase 1NCT04864379

Clinical Study of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and RFA in Patients With Solid Tumors

A Phase 1 study testing iNeo-Vac-P01, GM-CSF and PD-1 in people with Advanced Malignant Solid Tumor, run by Sir Run Run Shaw Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This research study is evaluating a new type of personalized neoantigen cancer vaccine（iNeo-Vac-P01）combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Solid Tumor
What is being tested?
iNeo-Vac-P01, GM-CSF and PD-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
3 Sep 2020to 3 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must freely sign informed consent;
  • Aged 18 to 75 years old;
  • Life expectancy of greater than 3 months.
  • At least one measurable lesion according to RECIST 1.1 criteria(Radiofrequency ablation of lesions was excluded).
  • histologically confirmed Advanced solid tumors,
  • have failed standard treatment, or unsuitable to receive standard treatment
Show all 14Show fewer
  • Liver metastases are present and are suitable for radiofrequency ablation；
  • agreeable to allow tumor and normal samples to be submitted for complete exome and transcription sequencing.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  • Good hematopoietic function ， defined as absolute neutrophils count ≥1.5×109 /L, platelet count ≥100 ×109 /L, and hemoglobin ≥90g/L；
  • Good liver function, defined as total bilirubin levels ≤1.5 times the upper normal limit (ULN), and glutamic-oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) levels ≤5 times ULN;
  • Good renal function, defined as serum creatinine ≤1.5 times ULN or calculated creatinine clearance ≥ 60 mL /min (Cockcroft-Gault formula); Routine urine examination urine protein less than 2+, or 24 hours urine protein quantitative <1g;
  • Good coagulation function, defined as INR or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, PT is acceptable as long as it is within the range of anticoagulant drug use；
  • Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;

Who cannot join

  • Currently participating in an interventional clinical study treatment or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
  • Major surgical treatment within 3 weeks prior to first administration;
  • Completed palliative radiotherapy within 7 days prior to first administration;
  • Clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
  • Have none suitable neoantigen;
  • Have been bone marrow or stem cell transplants;
Show all 24Show fewer
  • Clinically uncontrollable pleural effusion/peritoneal effusion/pericardial effusion;
  • Severe known allergic reactions (≥ grade 3) to the active ingredient and/or any excipient of PD-1 monoclonal antibody；
  • Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial administration；
  • Diagnosed with immunodeficiency or was receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dosing of the study；
  • Full recovery from toxicity and/or complications associated with any intervention has not been achieved prior to the commencement of treatment；
  • Other tumors diagnosed within 5 years prior to initial administration, exceptions include radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ;
  • Symptoms of central nervous metastasis
  • A history of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
  • Active infections that require systemic treatment;
  • A known presence of mental illness or substance abuse conditions that may affect compliance with the test requirements;
  • Human immunodeficiency virus (HIV) infection；
  • Untreated active hepatitis B；
  • Active subjects with HCV infection；
  • vaccine was administered within 30 days prior to initial administration (cycle 1, day 1)；
  • Medical history or evidence of disease, abnormal values of treatment or laboratory tests, or other conditions deemed inappropriate by the Investigator to interfere with the results of the study, prevent subjects from participating fully in the study;
  • breastfeeding women. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary impairment, etc.;
  • Patients whose cardiopulmonary function cannot tolerate anesthesia；
  • The investigator evaluates other circumstances that may affect the conduct of the clinical study and the judgment of the study results.

Trial locations and contacts

1 site in 1 country.

Fang Yong, MD, PhD contact

+86-571-87887821

307480770@qq.com

China1 site, 1 recruiting

  • Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Fang Yong, MD, PhD, +86-571-87887821, 307480770@qq.com

    Fang Yong, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: Safety, Tolerability and Immunogenicity of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and Radiofrequency Ablation in Patients With Advanced Solid Tumors

This research study is evaluating a new type of personalized neoantigen cancer vaccine（iNeo-Vac-P01）combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. The primary objective of this trial is to evaluate safety, tolerability and immunogenicity of iNeo-Vac-P01 in combination with anti-PD-1 and radiofrequency ablation, so as to provide a new personalized therapeutic strategy for patients.

It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Being tested
iNeo-Vac-P01, GM-CSF, PD-1, RFA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iNeo-Vac-P01Biological

    Also called Neoantigen peptides

    iNeo-Vac-P01: 300 mcg per peptide

  • GM-CSFOther

    Also called immune adjuvant, granulocyte-macrophage colony stimulating factor

    GM-CSF: 40 mcg

  • PD-1Drug

    Also called PD-1 inhibitor

    PD-1: 200mg administered by intravenous infusion every 2 weeks.

  • RFAProcedure or surgery

    Also called Radiofrequency ablation

    Radiofrequency ablation surgery

Study groups in NCT04864379
Study groupRoleWhat they receive
RFA+PD-1+iNeo-Vac-P01ExperimentalPatients will undergo radiofrequency ablation. At Week 3, patients will receive PD-1 at a dose of 200mg administered by intravenous infusion (IV) every 2 weeks. At Week 12,all patients,regardless of their disease status,iNeo-Vac-P01(300mcg per peptide)+ GM-CSF (40mcg) on days 1, 4, 8, 15, 22, 52, and 82 from week 12. Additional booster vaccines might be administered depending on ethics and patients' potential benefit.
Receives: Biological: iNeo-Vac-P01; Other: GM-CSF; Drug: PD-1; Procedure: RFA
RFA+iNeo-Vac-P01+PD-1ExperimentalPatients will undergo radiofrequency ablation. At Week 12, patients will receive iNeo-Vac-P01(300mcg per peptide)+ GM-CSF (40mcg) on days 1, 4, 8, 15, 22, 52, and 82 from week 12. Additional booster vaccines might be administered depending on ethics and patients' potential benefit. At Week 16, patients,regard of their disease status,will receive PD-1 at a dose of 200mg administered by intravenous infusion (IV) every 2 weeks.
Receives: Biological: iNeo-Vac-P01; Other: GM-CSF; Drug: PD-1; Procedure: RFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants experiencing clinical and laboratory adverse events (AEs)

    Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.

    Measured: 1 year

  2. Objective Response Rate

    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study.

    Measured: 5 years

  3. Measurement of CD4/CD8 T lymphocyte subsets.

    CD4/CD8 T lymphocyte subsets were detected by flow cytometry.

    Measured: 3 years

  4. The IFN-γ T cells responses induced by neoantigen

    The response of IFN-γ T cells induced by neoantigen was detected by ELispot.

    Measured: 2 years

Secondary outcomes (3)

  1. Overall Survival(OS)

    Time from surgery to death or last follow-up.

    Measured: 5 years

  2. Progression-free Survival(PFS)

    Time from surgery to any progression.

    Measured: 3 years

  3. Peripheral blood T cell receptor sequencing analysis

    The diversity and clonability of T cells were analyzed by peripheral blood T cell receptor sequencing.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start3 Sep 2020
  3. Primary completion3 Aug 2025 (estimated)
  4. Study completion3 Aug 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04864379
Sponsor's protocol ID
INEO-P-003
Status last verified
Apr 2021
First submitted
25 Apr 2021
Last updated
28 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fang Y, Mo F, Shou J, Wang H, Luo K, Zhang S, Han N, Li H, Ye S, Zhou Z, Chen R, Chen L, Liu L, Wang H, Pan H, Chen S. A Pan-cancer Clinical Study of Personalized Neoantigen Vaccine Monotherapy in Treating Patients with Various Types of Advanced Solid Tumors. Clin Cancer Res. 2020 Sep 1;26(17):4511-4520. doi: 10.1158/1078-0432.CCR-19-2881. Epub 2020 May 21.

    PubMed 32439700

  • 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.

    PubMed 33064988

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing iNeo-Vac-P01, GM-CSF and PD-1 in people with Advanced Malignant Solid Tumor, run by Sir Run Run Shaw Hospital 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 14 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fang Yong, MD, PhD (+86-571-87887821, 307480770@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants experiencing clinical and laboratory adverse events (AEs) (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT04864379, which also lists 2 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 28 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in