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MelanomaPhase 1NCT04197882

Clinical Study to Evaluate OrienX010 in Combination With Toripalimab as Neoadjuvant Treatment in Advanced Melanoma

A Phase 1 study testing OrienX010 Combination with Toripalimab injection in people with Melanoma, run by Peking University Cancer Hospital & Institute 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This study is an open-label, Phase Ib clinical study to evaluate recombinant human GM-CSF herpes simplex virus intratumoral injection (OrienX010) in combination with recombinant humanized anti-PD-1 monoclonal antibody infusion (Toripalimab) as neoadjuvant treatment in patients with complete resectable stage III and IV… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma
What is being tested?
OrienX010 Combination with Toripalimab injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
27 May 2019to 27 May 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

  • An ICF approved by the Ethic Committee will voluntarily signed by the patient prior to initiating any screening or specific study procedures;
  • Male or female patients between 18 and 75 years of age;
  • Patients with definite diagnosis of complete resectable stage III and IV melanoma (M1a) based on histology and/or cytology, and with at least 1 measurable lesion(s).
  • Patients with ECOG performance status of 0 or 1;
  • Expected Survival> 4 months;
  • The patient has good function in each organ, and the following conditions are required at screening according to the laboratory reference range:
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  • White blood cell count ≥ 3.0 × 109/L;
  • Absolute neutrophil value ≥ 1.5 × 109/L;
  • Platelet count ≥ 100 × 109/L;
  • Hemoglobin ≥ 90 g/L;
  • Serum albumin ≥ 2.5 g/dL;
  • Liver function tests: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN;
  • Renal function tests: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min at 24 hours (Cockcroft and Gault formula);
  • International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) or partial prothrombin time (PTT) ≤ 1.5 × ULN;
  • 7. Female patients with childbearing potential (including premature menopause, menopausal < 2 years and non-surgical sterilization), male patients, and partners of male patients must agree to use effective contraception during the study: Surgical sterilization, oral contraceptives, intrauterine devices, sexual abstinence or barrier contraceptive combination spermicides; All patients must continue contraception for 6 months after the last treatment.

Who cannot join

  • Patients previously treated with T-VEC or similar; Patients previously treated with anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody or similar;
  • Patients with negative anti-herpes simplex virus type I (HSV-1) antibodies IgG and IgM ;
  • The patient's lesion does not meet the requirement of the intratumoral injection volume or is not suitable for intratumoral injection;
  • Received anti-herpes simplex virus therapy (such as aciclovir, ganciclovir, valaciclovir, and arabinoside) within 4 weeks prior to the first dose of study treatment;
  • Received another anti-tumor monoclonal antibody (mAb) within 4 weeks prior to the first dose of study treatment or hasn't recover (≤ Grade 1) from adverse events due to prior therapy (occurring earlier than 4 weeks) ;
  • Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment. Note: Except for fully treated stage 1 or 2 basal/squamous cell carcinoma of the skin, superficial bladder cancer, or in situ cancer that is treated with potentially curative therapy;
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  • Patients with known hypersensitivity to the study drug, its active ingredient, excipients;
  • Patient with HBsAg positive and HBV DNA copies > 1×103copies/mL;
  • Patients with positive hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies;
  • Patients with any unstable systemic disease, including but not limited to: Serious infection, uncontrolled diabetes mellitus, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, and serious arrhythmia liver, kidney, or metabolic disease requiring medical treatment;
  • patients with active CNS metastases. patients may participate in the study if their CNS is adequately treated and their neurological symptoms recover to levels less than or equal to Grade 1 (CTCAE) for at least 2 weeks before enrollment, with the exception of residual signs or symptoms associated with CNS therapy . In addition, patients must be those who do not use corticosteroids or who take stable doses of ≤ 10 mg prednisone/day (or equivalent dose) or who decrease to ≤ 10 mg prednisone/day;
  • Patients with autoimmune disease, received liver or other organs transplantation once before, active pulmonary tuberculosis; or patients received major surgical procedures, live vaccination, immunotherapy 4 weeks prior to study initiation
  • Tumor's macrovascular invasion in the iliac and femoral vessels;
  • The disease (e.g., mental illness, etc.) or condition (e.g., alcoholism or drug abuse, etc.) of the patient may increase the patient's risk of receiving trial medication or affect the patient's compliance with the study requirements, or may confuse the study results;
  • Within 30 days of screening, the patient had received any other study product or had participated in another intervention clinical trial;
  • Pregnant or lactating women, or women who are prepared to become pregnant or lactating during the study; Men or women who are unwilling to use effective contraception;
  • Other situations that the investigators think are not suitable for inclusion

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: An Open-Label, Phase Ib Clinical Study to Evaluate OrienX010 in Combination With Toripalimab as Neoadjuvant Treatment in the Patients With Complete Resectable Stage III and Stage IV (M1a) Melanoma

This study is an open-label, Phase Ib clinical study to evaluate recombinant human GM-CSF herpes simplex virus intratumoral injection (OrienX010) in combination with recombinant humanized anti-PD-1 monoclonal antibody infusion (Toripalimab) as neoadjuvant treatment in patients with complete resectable stage III and IV (M1a) melanoma.

This study is planned to enroll approximately 30 patients with stage III and IV melanoma (M1a) who meet protocol requirements.

This study is to evaluate the efficacy and safety of recombinant human GM-CSF herpes simplex virus intratumoral injection (OrienX010) in combination with recombinant humanized anti-PD-1 monoclonal antibody infusion (Toripalimab infusion) as neoadjuvant treatment in the patients with complete resectable stage III and IV (M1a) melanoma.

Conditions
Melanoma
Being tested
OrienX010 Combination with Toripalimab injection
Keywords
complete resectable, melanoma, neoadjuvant treatment
Medical subject headings
Melanoma

What participants receive

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

  • OrienX010 Combination with Toripalimab injectionBiological

    Also called Recombinant Human GM-CSF Herpes Simplex Virus intratumoral Injection combination with Recombinant Human Anti-PD-1 Monoclonal Antibody infusion

    OrienX010 Produced by Oriengene Biotechnology Co.,Ltd. Strength: 1.0 mL/vial. Toripalimab infusion Produced by Junshi Biosciences Co., Ltd. Strength: 240 mg/6 mL/vial; Sterile water injection dosage form; Expiry date: 24 months; Date of manufacture: Based on the date of manufacture indicated in the product package.

Study groups in NCT04197882
Study groupRoleWhat they receive
treatmentExperimentalThis study consisted of 3 stage of neoadjuvant treatment, surgical, and adjuvant treatment. Neoadjuvant treatment period: OrienX010 intratumoral injection in combination with Toripalimab infusion. Toripalimab : 3 mg/kg, IV infusion: Once every 2 weeks for 6 doses ; OrienX010: Maximum injection volume 8 × 108 pfu, intratumoral injection: Once every 2 weeks for 6 doses ; Surgical treatment period: 2 weeks after the last dose of neoadjuvant treatment (± 7 days), the investigator designed the surgical protocol of the melanoma radical surgery according to the patient's individual disease, and performed postoperative care according to the patient's condition. Adjuvant treatment period: 3 weeks after operation (± 7 days), the patient was given Toripalimab infusion. Toripalimab 3 mg/kg intravenously given every 3 weeks (every 3 weeks per cycle) for up to 1 year (the one-year duration will be counted from 1st dose in neoadjuvant treatment).
Receives: Biological: OrienX010 Combination with Toripalimab injection

What is being measured

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

  1. pathological response rates

    pCR and Major PR/Near pCR rates

    Measured: 12 week of treatment

  2. Clinical effective rate

    objective response rates based on RECIST 1.1, include CR,PR,SD

    Measured: 12 week of treatment

Secondary outcomes (5)

  1. RFS

    To evaluate 1-year relapse-free survival (RFS) and 2-year relapse-free survival

    Measured: 1-year and 2-year after surgery

  2. OS

    overall survival

    Measured: approximate 3 years

  3. the safety of OrienX010 in combination with Toripalimab

    Number of participants with treatment-related SAE and adverse events that assessed by CTCAE v5.03

    Measured: From date of enrolling to 90 days after end of treatment

  4. The surgical operation related events were observed

    observe the surgical operation related events

    Measured: Surgical treatment period

  5. Clinical effective rate

    Objective response rates based on iRECIST and it-RECIST, include CR,PR,SD

    Measured: 12 week of treatment

Timeline

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

  1. First posted13 Dec 2019
  2. Study start27 May 2019
  3. Primary completion27 May 2021 (estimated)
  4. Study completion27 May 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197882
Sponsor's protocol ID
OrienX010-II-12
Status last verified
Feb 2021
First submitted
10 Dec 2019
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao Q, Du Y, Li L, Mao L, Wang X, Xu Z, Liu J, Cui C, Chi Z, Gao X, Liu K, Chang S, Kong Y, Sheng X, Xia X, Guo J, Dai J, Si L. Long-term survival benefit of neoadjuvant oncolytic virus plus PD-1 blockade in acral melanoma: implications of STING in resistance and potential therapy. Exp Hematol Oncol. 2026 Jun 1;15(1):71. doi: 10.1186/s40164-026-00786-0.

    PubMed 42226303

  • Liu J, Wang X, Li Z, Gao S, Mao L, Dai J, Li C, Cui C, Chi Z, Sheng X, Lai Y, Tan Z, Lian B, Tang B, Yan X, Li S, Zhou L, Wei X, Li J, Guo J, Si L. Neoadjuvant oncolytic virus orienx010 and toripalimab in resectable acral melanoma: a phase Ib trial. Signal Transduct Target Ther. 2024 Nov 22;9(1):318. doi: 10.1038/s41392-024-02029-2.

    PubMed 39572525

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OrienX010 Combination with Toripalimab injection in people with Melanoma, run by Peking University Cancer Hospital & Institute 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 15 inclusion and 17 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 10 Feb 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological response rates (time frame: 12 week of treatment). The study lists 2 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 NCT04197882, 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 10 Feb 2021.

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