Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients

NCT03228836 | Completed Phase 2 Results

• 1 other identifier: CIBI308D201
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is phase II study. Efficacy and safety evaluation of IBI308 in patients with relapsed/refractory extranodal NK/T cell lymphoma, nasal type: a multicenter, single arm.

Conditions

Effect of Drugs

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Before First PD

  The tumor assessment is according to Lugano 2014 Criteria and then International Working Group (IWG) 2007 Criteria after 24 weeks. Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrollment to termination of trial treatment (per Lugano 2014 criteria during intial 24 weeks, per IWG 2007 criteria after 24 weeks). The primary efficacy endpoint is ORR evaluated using the 2014 Lugano Criteria before first progression disease (PD).

  Up to ~30 months (through database cut-off date of 28-February-2020)

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  Up to ~30 months (through database cut-off date of 28-February-2020)

• Duration of Response (DOR)

  Up to ~30 months (through database cut-off date of 28-February-2020)

Study Arms (1)

Sintilimab (IBI308)

EXPERIMENTAL

Drug: Sintilimab

Interventions

Sintilimab DRUG

Sintilimab (IBI308) 200mg IV Q3W

Sintilimab (IBI308)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed ENKL-NT.
• Relapsed or refractory ENKTL-NT. Being relapsed is defined as presence of new lesions at the primary location or other sites after achieving CR; being refractory is defined as any one of the followings: PD after 2 treatment cycles, PR not achieved after 4 treatment cycles, or CR not achieved after 6 treatment cycles. Patients who do not response or patients with relapsed disease or PD after autologous stem cell transplantation can enroll.
• Must have been treated with asparaginase-based regimen (radiotherapy must be performed for stage I/II disease).
• Long axis of a lesion \> 15 mm or 18FDG-PET uptake by lesion.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores of 0-2.
• Signed the inform consent form (ICF) and able to comply with the scheduled follow-up visits and related procedures required in the protocol.
• Between the ages of ≥18 to ≤70 years.
• Life expectancy≥ 12 weeks.
• Patients (female patients at childbearing age or male patients whose partners are at childbearing age) must take effective contraceptive measures during the entire course of the trial and within 90 days since the last dose of treatment.
• Adequate organs and bone marrow functions, as defined below: Count of whole blood cells: absolute neutrophil count (ANC) ≥1.0×10\^9/L, platelets (PLTs) count ≥ 50×10\^9/L, hemoglobin (HGB) ≥ 8.0 g/L; granulocyte colony-stimulating factor, PLT, or red blood cell (RBC) transfusion has not been performed within 7 days prior to the test. Hepatic function: total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. Renal function:serum creatinine (Cr) ≤ 1.5 × ULN. Thyroid function: normal thyroid stimulating hormone (TSH) at baseline, or abnormal TSH at baseline with normal thiiodothronine (T3)/thiiodothronine (T4) and no symptoms.

You may not qualify if:

• Patients with aggressive NK cell leukemia.
• Patients with primary or secondary central nervous system (CNS) lymphoma.
• Patients with severe hemophagocytic syndrome at initial diagnosis of ENKTL-NT.
• Patients with pulmonary great vessel invasion.
• Previous exposure to any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
• Enrolled in another interventional clinical study, unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study.
• Received any investigational drug within 4 weeks prior to the first dose of study treatment.
• The last dose of radiation or anti-tumor therapy (chemotherapy, targeted therapy or tumor embolization) was within 3 weeks prior to receiving the first dose of study treatment; the last dose of nitrosourea or mitomycin C treatment was within 6 weeks prior to receiving the first dose of study treatment.
• Received immunosuppressants within 4 weeks prior to the first dose of study treatment, excluding local glucocorticoids administered by nasal, inhaled, or other topical routes, or systemic glucocorticoids of physiological doses (no more than 10 mg/day of prednisone or equivalents).
• Received any live attenuated vaccine within 4 weeks prior to the first dose of study treatment, or is scheduled to receive live attenuated vaccine during the study period.
• Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or has unhealed wounds, ulcers, or fractures.
• Active, known, or suspected autoimmune disease (see Appendix 6) or previous medical history of these diseases within 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment, hypothyroidism only requiring thyroid replacement, or type I diabetes only requiring insulin can enroll).
• Known history of primary immunodeficiency diseases.
• Known active pulmonary tuberculosis.
• Known history of allogeneic organ transplantation or allogeneic hem atopoietic stem cell transplantation.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Jiangsu Provincial Hospital

Nanjing, Jiangsu, China

Location

Related Publications (1)

• Tao R, Fan L, Song Y, Hu Y, Zhang W, Wang Y, Xu W, Li J. Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4). Signal Transduct Target Ther. 2021 Oct 27;6(1):365. doi: 10.1038/s41392-021-00768-0.

  PMID: 34702811 DERIVED

MeSH Terms

Interventions

sintilimab

Results Point of Contact

• Title: Yi Bo
• Organization: Innovent Biologics (Suzhou) Co., Ltd. (seal)

jessica.yi@innoventbio.com

+8613382419112

Study Officials

• Jian-yong Li, Master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: July 25, 2017
• Study Start: August 23, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: January 12, 2021
• Results First Posted: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)