The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Interferons

Criteria

Inclusion Criteria:

1. Male and Female aged between 18 and 75 years are eligible;

2. It was confirmed by histopathology that it was a acral melanoma;

3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

4. 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;

5. No adjuvant therapy was received;

6. No treatment contraindication, peripheral blood, normal liver, kidney function and electrocardiogram are normal; ANC≥1.5×10^9/L,PLT≥90×10^9/L,Hgb≥90.g/dL; serum urea nitrogen, cr≤1.5*ULN; ALT,ASTI≤2.5*ULN,

7. 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：

1. Mucosal-derived melanoma, uveal melanoma.

2. Previous exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1 / 2 antibody or interferon.

3. Hyperthyroidism or hypothyroidism. Note: Subjects who are stable after hormone replacement therapy can be enrolled.

4. Participate in another clinical study at the same time.

5. Have received any research drug within 4 weeks before the first dose of study treatment.