A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed.
- •Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy.
- •Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Has at least one measurable lesion per Lugano 2014 classification.
- •Is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review.
- •Has adequate organ function.
- •Has life expectancy of greater than 3 months.
排除标准
- •Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis.
- •Has known additional malignancy within 5 years prior to randomization.
- •Has an active autoimmune disease or has had an autoimmune disease that may relapse.
- •Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment.
- •Has active tuberculosis infection.
- •Has a known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome (AIDS).
- •Has a known active Hepatitis B or C virus infection.
- •Has received systemic anti-cancer therapy within 28 days before the first dose of study treatment, including chemotherapy, immunotherapy, biological therapy (e.g. cancer vaccine, cytokine therapy or growth factors to treat cancer).
- •Has used traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of study treatment.
- •Has received systemic corticosteroid or any other immunosuppressive therapy within 14 days before the first dose of study treatment.
- •Has received any treatment of antibody or drug that targets at T-cell coregulatory pathways or immune checkpoint pathways.
- •Has toxicity from prior anti-cancer treatment, except for alopecia and fatigue, that has not recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 before the first dose of study treatment.
- •Has had allogenic hematopoietic stem cell transplantation (HSCT) within 5 years or autologous HSCT within 90 days before the first dose of study treatment.
- •Has a known severe hypersensitivity to sugemalimab, its active substance and/or any of its excipients, or to other monoclonal antibodies.
- •Female participants who are pregnant or breastfeeding.
- •Is currently participating in or has participated in a trial of an investigational agent within 28 days before to the first dose of study treatment.
研究组 & 干预措施
Sugemalimab+PGemOx
Participants receive sugemalimab 1200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Pegaspargase (Drug)
Placebo+PGemOx
Participants receive placebo via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Pegaspargase (Drug)
Placebo+PGemOx
Participants receive placebo via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Oxaliplatin (Drug)
Sugemalimab+PGemOx
Participants receive sugemalimab 1200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Oxaliplatin (Drug)
Sugemalimab+PGemOx
Participants receive sugemalimab 1200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Gemcitabine (Drug)
Placebo+PGemOx
Participants receive placebo via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Gemcitabine (Drug)
Placebo+PGemOx
Participants receive placebo via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Placebo (Drug)
Sugemalimab+PGemOx
Participants receive sugemalimab 1200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 & 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1.
干预措施: Sugemalimab (Biological)
结局指标
主要结局
Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
时间窗: Approximately 39 months after First Patient In
次要结局
- Objective response rate (ORR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification(Approximately 39 months after First Patient In)
- Overall survival (OS)(Approximately 39 months after First Patient In)
- Progression-free survival (PFS) evaluated by the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification(Approximately 39 months after First Patient In)
- Duration of response (DoR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification(Approximately 39 months after First Patient In)