Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Molgramostim

Immunoglobulins

Sargramostim

This 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).

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.

OrienX010 Combination with Toripalimab injection

Jun Guo, MD

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.

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

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

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

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

observe the surgical operation related events

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

Spots Global Cancer Trial Database for complete resectable