Clinical trial NCT04602065: Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Extranodal NK/T Cell Lymphoma, Nasal Type
Keywords: ENKTL
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria;
2. 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.
3. Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously).
4. With measurable foci, defined as: lymph nodes with long diameters\>15mm，extra-nodal foci\>10mm on CT scan;
5. ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1;

Exclusion Criteria:

1. Invasive NK cell leukemia;
2. Primary CNS lymphoma or CNS-involved lymphoma;
3. Patients with hemophagocytic syndrome;
4. Patients with lymphoma invading large pulmonary vessels;
5. 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).

Primary outcomes:
measure: ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
Secondary outcomes:
measure: ORR
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
measure: CR/PR
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
measure: DCR
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
measure: TTR2016 criteria.)
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
measure: DOR
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
measure: PFS
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
measure: OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.)
timeFrame: After the last subject completed follow-up visit of up to 24 weeks
measure: adverse events
timeFrame: from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
References: