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Clinical Study to Evaluate OrienX010 in Combination With Toripalimab as Neoadjuvant Treatment in Advanced Melanoma | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT04197882•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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 (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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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, and with at least 1 measurable lesion(s).
•4. Patients with ECOG performance status of 0 or 1;
•5. 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:
•White blood cell count ≥ 3.0 × 109/L;
•Absolute neutrophil value ≥ 1.5 × 109/L;
•Platelet count ≥ 100 × 109/L;
•Hemoglobin ≥ 90 g/L;
+5 more criteria

Exclusion Criteria

•1. 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;
•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;
+7 more criteria

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 27, 2019

Primary Completion Date

May 27, 2021

Completion Date

May 27, 2025

Last Updated

February 10, 2021

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

OrienX010 Combination with Toripalimab injection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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