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

Primary Purpose

Extranodal NK/T Cell Lymphoma, Nasal Type

Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal NK/T Cell Lymphoma, Nasal Type focused on measuring ENKTL

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Previously received anti-PD1/PD-L1 antibodies

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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)
DCR
To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
TTR2016 criteria.)
To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
DOR
To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
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)
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)
adverse events
To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)

Full Information

First Posted
September 30, 2020
Last Updated
March 12, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04602065
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T Cell Lymphoma, Nasal Type
Keywords
ENKTL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Previously received anti-PD1/PD-L1 antibodies
Arm Type
Experimental
Arm Description
Patients previously received anti-PD1/PD-L1 antibodies, except for those were primarily refractory to them.
Arm Title
Patients previously never received anti-PD1/PD-L1 antibodies
Arm Type
Experimental
Arm Description
Patients previously never received anti-PD1/PD-L1 antibodies.
Intervention Type
Drug
Intervention Name(s)
IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
Intervention Description
IBI318, 300mg, Q2W, Intravenous influsion.
Primary Outcome Measure Information:
Title
ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)
Description
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Secondary Outcome Measure Information:
Title
ORR
Description
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
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Title
CR/PR
Description
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)
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Title
DCR
Description
To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Title
TTR2016 criteria.)
Description
To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Title
DOR
Description
To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Title
PFS
Description
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)
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Title
OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.)
Description
To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time Frame
After the last subject completed follow-up visit of up to 24 weeks
Title
adverse events
Description
To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Time Frame
from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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