Clinical Study to Evaluate OrienX010 in Combination With Treprizumab Injection as Neoadjuvant Treatment in Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04197882|
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : December 16, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- pathological response rates [ Time Frame: 8 week of treatment ]pCR and Major PR/Near pCR rates
- ORR [ Time Frame: 8 week of treatment ]objective response rates
- RFS [ Time Frame: 1-year and 2-year after treatment ]To evaluate 1-year relapse-free survival (RFS) and 2-year relapse-free survival
- OS [ Time Frame: approximate 3 years ]overall survival
- 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
- The surgical operation related events were observed [ Time Frame: Surgical treatment period ]observe the surgical operation related events
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
|Contact: Xuan Wang, MDfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Jun Guo, MD 010-88121122 email@example.com|
|Principal Investigator:||Jun Guo, MD||Beijing Cancer Hospital|