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

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04602065

Collaborator

(none)

129

Enrollment

Location

Arms

25.2

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK/T Cell Lymphoma, Nasal Type	Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

129 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 24, 2020

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Previously received anti-PD1/PD-L1 antibodies 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) IBI318, 300mg, Q2W, Intravenous influsion.
Experimental: Patients previously never received anti-PD1/PD-L1 antibodies Patients previously never received anti-PD1/PD-L1 antibodies.	Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) IBI318, 300mg, Q2W, Intravenous influsion.

Arm

Intervention/Treatment

Experimental: Previously received anti-PD1/PD-L1 antibodies

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)

IBI318, 300mg, Q2W, Intravenous influsion.

Experimental: Patients previously never received anti-PD1/PD-L1 antibodies

Patients previously never received anti-PD1/PD-L1 antibodies.

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

IBI318, 300mg, Q2W, Intravenous influsion.

Outcome Measures

Primary Outcome Measures

ORR(evaluated by the independent review committee according to Lyric 2016 criteria.) [After the last subject completed follow-up visit of up to 24 weeks]
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).

Secondary Outcome Measures

ORR [After the last subject completed follow-up visit of up to 24 weeks]
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
CR/PR [After the last subject completed follow-up visit of up to 24 weeks]
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)
DCR [After the last subject completed follow-up visit of up to 24 weeks]
To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
TTR2016 criteria.) [After the last subject completed follow-up visit of up to 24 weeks]
To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
DOR [After the last subject completed follow-up visit of up to 24 weeks]
To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
PFS [After the last subject completed follow-up visit of up to 24 weeks]
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)
OS(evaluated 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]
To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
adverse events [from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.]
To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).