NCT03430297

A Randomized, Controlled, Multi-center, Phase III Clinical Study to Investigate Recombinant Humanized PD-1 Monoclonal Antibody Injection (JS001) Versus Dacarbazine as the 1st-line Therapy for Unresectable or Metastatic Melanoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is one phase III, randomized, open-label study in comparison of JS001 with dacarbazine as the 1st-line therapy for adult (≥18 years) subjects with unresectable or metastatic melanoma. The subjects will be 1:1 randomized and stratified in accordance with acral lentiginous melanoma and M stage (M0vsM1a/M1bvsM1c). Using standard dose and dose interval, the subjects will be given JS001 240mg intravenously, once every two weeks, or dacarbazine 1000mg/m2, d1, intravenously, once every three weeks. One cycle of therapy is 6 weeks (3 doses of JS001 or 2 doses of dacarbazine per cycle).

Detailed description

1. In the subjects who have clinical benefit evaluated by investigators and tolerate the study treatment, treatment will be considered to give after occurrence of progression defined by RECIST1.1 as evaluated by the initial investigators, these subjects must terminate the treatment when further progression is validated. 2. The subjects in dacarbazine treatment group are allowed to be crossed to receive JS001 after progression of disease; however, they need to be re-evaluated if they meet the inclusion/exclusion criteria. Subjects need to provide one tumor tissue specimen for archival or one newly acquired biopsy tissue from the site that is previously not irradiated for evaluation of PD-L1 expression status when they participate in the study. The PD-L1 expression status of specimen will be evaluated in the central laboratory using immunohistochemical (IHC) method. Subjects with positive or negative PD-L1 can be enrolled in this study, and the clinical activity in the two subgroups will be evaluated in accordance with the prespecified subgroup analysis.

Conditions

• Metastatic Melanoma
• Unresectable Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	JS001 240mg Q2W	recombinant humanized anti-PD-1 monoclonal antibody injection (JS001) will be provided by the sponsor. Strength: 240mg/6ml/vial. 240mg, once every two weeks. Control drug: dacarbazine (1000mg/m2, d1, intravenously, once every three weeks). The dose will be given intravenously over 180 minutes (the infusion time can be prolonged according to the institutional criteria), starting from Week 1, once every 3 weeks, until progression of disease.
DRUG	Dacarbazine 1000mg/m2 Q3W	The dose of DTIC will be calculated according to the following formula, where the 'X' represents the total mg dose of DTIC: X (mg) = \[body surface area (BSA) x (1000mg/m2)\]. The body surface area (BSA) is defined by Dubois formula: BSA (m2) = 0.007184\* (cm0.725) \* (kg0.425)

Timeline

• Start date: 2018-02-02
• Primary completion: 2023-07-12
• Completion: 2023-11-27
• First posted: 2018-02-12
• Last updated: 2024-09-19

Locations

11 sites across 1 country: China