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Due to the company's development strategy adjustment ,Innovent Bioligics decided not to continue the study after consultation with investigators
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This is a phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI310 + IBI308 | Experimental | Participants will be treated with IBI310 in combination with IBI308 |
|
| IBI308 | Experimental | Participants will be treated with IBI308 |
|
| high-dose recombinant interferon a-2B | Active Comparator | Participants will be treated with recombinant interferon a-2B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI310+IBI308 | Drug | In this group, subjects will be given IBI310 3mg/kg IV Q3W in combination with IBI308 200mg IV Q3W for 4 cycles, then follow up a maintenance therapy performed with IBI310 3mg/kg IV Q12W in combination with IBI308 200mg IV Q3W until disease progression or loss of clinical benefit. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival rate | to evaluate the Recurrence free survival (RFS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon | up to 5 years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | to evaluate the Overall survival (OS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon | up to 5 years after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Beijing | China |
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| IBI308 | Drug | In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit |
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| High-dose recombinant interferon a-2B | Drug | In this group, subjects will be given 15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 9*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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