The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IBI310 + IBI308 Participants will be treated with IBI310 in combination with IBI308 |
Drug: IBI310+IBI308
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.
|
| Experimental: IBI308 Participants will be treated with IBI308 |
Drug: IBI308
In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit
|
| Active Comparator: high-dose recombinant interferon a-2B Participants will be treated with recombinant interferon a-2B |
Drug: High-dose recombinant interferon a-2B
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
|
Outcome Measures
Primary Outcome Measures
- Recurrence-free survival rate [up to 5 years after enrollment]
to evaluate the Recurrence free survival (RFS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
Secondary Outcome Measures
- Overall survival (OS) [up to 5 years after enrollment]
to evaluate the Overall survival (OS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and Female aged between 18 and 75 years are eligible;
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It was confirmed by histopathology that it was a acral melanoma;
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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Complete excision of primary focal area, surgical incision; All patients must have disease-free status documented by a complete physical examination and imaging studies prior to registration;
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No adjuvant therapy was received;
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No treatment contraindication, peripheral blood, normal liver, kidney function and electrocardiogram are normal; ANC≥1.5×109/L,PLT≥90×109/L,Hgb≥90.g/dL; serum urea nitrogen, cr≤1.5ULN; ALT,ASTI≤2.5ULN,
-
Female subjects of childbearing age or male subjects of women of childbearing age need effective contraception during the entire treatment period and 6 months after the treatment period
Exclusion Criteria：
-
Mucosal-derived melanoma, uveal melanoma.
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Previous exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1 / 2 antibody or interferon.
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Hyperthyroidism or hypothyroidism. Note: Subjects who are stable after hormone replacement therapy can be enrolled.
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Participate in another clinical study at the same time.
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Have received any research drug within 4 weeks before the first dose of study treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing cancer hospital | Beijing | China |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI310A301