Trials / Terminated
TerminatedNCT04277663
The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
A Phase 3, Open-label, Multicenter Study, IBI310 in Combination With IBI308 and IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | IBI308 | In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit |
| 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 |
Timeline
- Start date
- 2020-04-17
- Primary completion
- 2023-02-28
- Completion
- 2023-02-28
- First posted
- 2020-02-20
- Last updated
- 2023-03-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04277663. Inclusion in this directory is not an endorsement.