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Clinical Study to Evaluate OrienX010 in Combination With Treprizumab Injection as Neoadjuvant Treatment in Melanoma

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ClinicalTrials.gov Identifier: NCT04197882
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jun Guo, Beijing Cancer Hospital

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: OrienX010 Combination with Treprizumab injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase Ib Clinical Study to Evaluate OrienX010 in Combination With Treprizumab Injection as Neoadjuvant Treatment in the Patients With Complete Resectable Stage III and Stage IV (M1a) Melanoma
Actual Study Start Date : May 27, 2019
Estimated Primary Completion Date : May 27, 2021
Estimated Study Completion Date : May 27, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: treatment

This study consisted of 3 cycles of neoadjuvant treatment, surgical, and adjuvant treatment. Neoadjuvant treatment period: OrienX010 in combination with Treprizumab injection. Treprizumab injection: 3 mg/kg, IV infusion: Once every 2 weeks (1 treatment cycle every 2 weeks) for 4 doses (4 cycles); OrienX010: Maximum injection volume 8 × 108 pfu, intratumoral injection: Once every 2 weeks (1 treatment cycle every 2 weeks) for 4 doses (4 cycles); 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 Treprizumab injection. Treprizumab injection: 3 mg/kg intravenously given every 3 weeks (1 treatment cycle every 3 weeks) for up to 1 year.

Biological: OrienX010 Combination with Treprizumab injection
OrienX010 Produced by Oriengene Biotechnology Co.,Ltd. Strength: 1.0 mL/vial. Treprizumab injection 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.
Other Name: Recombinant Human GM-CSF Herpes Simplex Virus Injection combination with Recombinant Human Anti-PD-1 Monoclonal Antibody Injection




Primary Outcome Measures :
  1. pathological response rates [ Time Frame: 8 week of treatment ]
    pCR and Major PR/Near pCR rates

  2. ORR [ Time Frame: 8 week of treatment ]
    objective response rates


Secondary Outcome Measures :
  1. RFS [ Time Frame: 1-year and 2-year after treatment ]
    To evaluate 1-year relapse-free survival (RFS) and 2-year relapse-free survival

  2. OS [ Time Frame: approximate 3 years ]
    overall survival

  3. the safety of OrienX010 in combination with Treprizumab injection [ Time Frame: From date of enrolling to 90 days after end of treatment ]
    Number of participants with treatment-related SAE and adverse events that assessed by CTCAE v5.0

  4. The surgical operation related events were observed [ Time Frame: Surgical treatment period ]
    observe the surgical operation related events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An ICF approved by the Ethic Committee will voluntarily signed by the patient prior to initiating any screening or specific study procedures;
  2. Male or female patients between 18 and 75 years of age;
  3. Patients with definite diagnosis of complete resectable stage III and IV melanoma (M1a) based on histology and/or cytology.
  4. Patients with ECOG performance status of 0 or 1;
  5. Expected Survival> 4 months;
  6. The patient has good function in each organ, and the following conditions are required at screening according to the laboratory reference range:

    • 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.

Exclusion Criteria:

  1. Patients previously treated with T-VEC or similar; Patients previously treated with PD-1 or similar;
  2. Patients with negative anti-herpes simplex virus type I (HSV-1) antibodies IgG and IgM ;
  3. The patient's lesion does not meet the requirement of the intratumoral injection volume or is not suitable for intratumoral injection;
  4. Received anti-herpes simplex virus therapy (such as aciclovir, ganciclovir, valaciclovir, and arabinoside) within 4 weeks prior to the first dose of study treatment;
  5. 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) ;
  6. 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;
  7. Patients with known hypersensitivity to the study drug, its active ingredient, excipients;
  8. Patient with HBsAg positive and HBV DNA copies > 1×103copies/mL;
  9. Patients with positive hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies;
  10. 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;
  11. 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 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;
  12. Patients with autoimmune disease;
  13. Tumor's macrovascular invasion in the iliac and femoral vessels;
  14. 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;
  15. Within 30 days of screening, the patient had received any other study product or had participated in another intervention clinical trial;
  16. 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;
  17. Other situations that the investigators think are not suitable for inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197882


Contacts
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Contact: Xuan Wang, MD 010-88121122 w_xuan_md@126.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Guo, MD    010-88121122    guoj307@126.com   
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: Jun Guo, MD Beijing Cancer Hospital

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Responsible Party: Jun Guo, Director of department of renal cancer and melanoma, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT04197882    
Other Study ID Numbers: OrienX010-II-12
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Guo, Beijing Cancer Hospital:
complete resectable
melanoma
neoadjuvant treatment
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Molgramostim
Antineoplastic Agents