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
  • participants needed
    300
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
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Updated on 19 February 2024
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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.

Details
Condition Acral Melanoma That Has Been Removed by Surgery
Age 18years - 75years
Treatment IBI310+IBI308, IBI308, High-dose recombinant interferon a-2B
Clinical Study IdentifierNCT04277663
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male and Female aged between 18 and 75 years are eligible
It was confirmed by histopathology that it was a acral melanoma
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
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
No adjuvant therapy was received
No treatment contraindication, peripheral blood, normal liver, kidney function and electrocardiogram are normal; ANC1.510^9/L,PLT9010^9/L,Hgb90.g/dL; serum urea nitrogen, cr1.5 _ULN; ALT,ASTI2.5_ ULN
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
Previous exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1 / 2 antibody or interferon
Hyperthyroidism or hypothyroidism. Note: Subjects who are stable after hormone replacement therapy can be enrolled
Participate in another clinical study at the same time
Have received any research drug within 4 weeks before the first dose of study treatment
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