Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type), a Multicenter, Open-label Phase Ib/II Trial

Conditions
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Extranodal NK/T Cell Lymphoma, Nasal Type

Intervention / Treatment
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* Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria; Refractory and relapsed ENKTL patients, being relapsed is defined as re-occurrence of the same lymphoma lesions at the primary site or new sites after complete response (CR); being refractory is defined as having any of the following conditions: evaluated as stable disease (SD) or progression disease (PD) after 2 cycles of treatment; not being able to achieve partial response (PR) after 4 cycles of treatment; not being able to achieve complete response (CR) after 6 cycles of treatment. Patients that did not achieve remission, or relapsed/progressed after autologous stem cell transplantation (ASCT) could also be enrolled. Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously). With measurable foci, defined as: lymph nodes with long diameters>15mm，extra-nodal foci>10mm on CT scan; ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1; Exclusion Criteria: Invasive NK cell leukemia; Primary CNS lymphoma or CNS-involved lymphoma; Patients with hemophagocytic syndrome; Patients with lymphoma invading large pulmonary vessels; Patients primarily resistant to anti-PD1,PD-L1,PD-L2 antibodies (generally considered as those received anti- PD1,PD-L1,PD-L2 antibodies as monotherapy or in combination with chemotherapy, but did not achieve PR or CR in non-maintenance treatment).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Previously received anti-PD1/PD-L1 antibodies<br>Patients previously received anti-PD1/PD-L1 antibodies, except for those were primarily refractory to them. | Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)<br>* IBI318, 300mg, Q2W, Intravenous influsion.<br>|
| Experimental: Patients previously never received anti-PD1/PD-L1 antibodies<br>Patients previously never received anti-PD1/PD-L1 antibodies. | Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)<br>* IBI318, 300mg, Q2W, Intravenous influsion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ENKTL