NCT04200040

A Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Unresectable Malignant Melanoma Patients

A Phase II Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Previously Untreated With Dacarbazine Patients in Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Malignant Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: OrienGene Biotechnology Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is being performed to evaluate the safety and efficacy of Dacarbazine and OrienX010 therapy in Untreated Patients With Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Melanoma. The study will be conducted in about 6 centres in China and total 165 patients will be enrolled. All eligible Patients will be randomized between Dacarbazine and OrienX010 in a 1:2 ratio, so 1/3 (55) patients will receive the Dacarbazine and 2/3 (110) patients will receive the OrienX010. During the treatment phase, the patient will receive OrienX010 administration once biweekly or Dacarbazine once every 3 week until to the end of treatment (EOT). The duration of safety follow-up for adverse events (AEs) and serious adverse events (SAEs) will be to 90 days after the end of treatment. The details please refer to study schema. For patients who have completed the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event. After the end of study, if patient want to continue receiving the OrienX010 treatment and judged by investigator, sponsor will provide OrienX010 and Dacarbazine for free until disease progression/death or OrienX010 on marketing launch.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	OrienX010 injection	OrienX010 to be used in this study have been developed and manufactured by OrienGene Biotechnology Ltd. Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
DRUG	Dacarbazine (DTIC)	Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.

Timeline

• Start date: 2017-08-27
• Primary completion: 2022-12-27
• Completion: 2022-12-27
• First posted: 2019-12-16
• Last updated: 2020-02-27

Locations

1 site across 1 country: China