A Phase Ⅲ Study to Investigate JS001 Versus Dacarbazine as the First Line Therapy for Unresectable or Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT03430297|
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma Unresectable Melanoma||Biological: JS001 240mg Q2W Drug: Dacarbazine 1000mg/m2 Q3W||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Multi-center, Phase Ⅲ Clinical Study to Investigate Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection (JS001) Versus Dacarbazine as the First Line Therapy for Unresectable or Metastatic Melanoma|
|Actual Study Start Date :||February 2, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
|Experimental: JS001 240mg Q2W||
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.
|Active Comparator: Dacarbazine 1000mg/m2 Q3W||
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)
- the progression-free survival (PFS) [ Time Frame: 3 months ]To compare the progression-free survival (PFS) evaluated by one independent review board of radiological data in systemic treatment-naïve patients with unresectable, locally advanced or metastatic melanoma who are treated with JS001 versus dacarbazine.
- objective response rate (ORR) [ Time Frame: 2 years ]To compare objective response rate (ORR) evaluated by the independent review board of radiological data according to RECIST 1.1 between the two groups;
- duration of response (DOR) [ Time Frame: 2 years ]To compare duration of response (DOR) evaluated by the independent review board of radiological data according to RECIST 1.1 between the two groups;
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
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): NCT03430297
|Contact: Ling Xiaoemail@example.com|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Jun Guo, Phd; Md firstname.lastname@example.org|
|Principal Investigator: Jun Guo, PhD; MD|
|Wuhan Union Hospital||Not yet recruiting|
|Wuhan, Hubei, China|
|Contact: Li Fan 027-85873501 email@example.com|
|Sub-Investigator: Li Fan, Phd,MD|
|Principal Investigator: Jing Chen, Phd,MD|
|Yunnan Cancer Hospital||Not yet recruiting|
|Kunming, Yunnan, China|
|Contact: Ying Wang, Phd,MD 0871-68179173 firstname.lastname@example.org|
|Principal Investigator: Xin Song, Phd,MD|
|Sub-Investigator: Ying Wang, Phd,MD|
|Principal Investigator:||Jun Guo||Beijing Cancer Hospital|