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Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
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The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously received anti-PD1/PD-L1 antibodies | Experimental | Patients previously received anti-PD1/PD-L1 antibodies, except for those were primarily refractory to them. |
|
| Patients previously never received anti-PD1/PD-L1 antibodies | Experimental | Patients previously never received anti-PD1/PD-L1 antibodies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) | Drug | IBI318, 300mg, Q2W, Intravenous influsion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR(evaluated by the independent review committee according to Lyric 2016 criteria.) | To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type). | After the last subject completed follow-up visit of up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) determined by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria | After the last subject completed follow-up visit of up to 24 weeks |
| CR/PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangdong | China |
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To evaluate the complete response (CR) rate and partial response (PR) rate of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
| After the last subject completed follow-up visit of up to 24 weeks |
| DCR | To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks |
| TTR2016 criteria.) | To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks |
| DOR | To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks |
| PFS | To evaluate the progression-free survival (PFS) and PFS rate at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks |
| OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.) | To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks |
| adverse events | To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first. |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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