Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic Nasopharyngeal Carcinoma After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC). It is expected to investigate a novel therapeutic regimen with improved efficacy and enhanced safety for recurrent/metastatic NPC, thereby providing robust evidence-based medical support for the application of dual-target immune checkpoint inhibitors in nasopharyngeal carcinoma therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status score of 0-1;
- •Age 18 to 70 years;
- •Histologically confirmed nasopharyngeal carcinoma;
- •Patients with locoregional recurrence unsuitable for surgery or radiotherapy, or those who developed distant metastasis after standard comprehensive treatment, or initially diagnosed with metastatic nasopharyngeal carcinoma, provided they have experienced treatment failure with first-line cisplatin-based regimens (± PD-1 monoclonal antibody);
- •Availability of nasopharyngeal + neck MRI data prior to enrollment, with at least one measurable lesion (excluding bone metastases);
- •Willingness to provide archived tumor tissue specimens or undergo a biopsy to collect tumor tissue for PD-L1 expression level testing;
- •Laboratory test results within 7 days prior to enrollment meeting the following criteria:
- •Hematology: Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L, hemoglobin (Hb) ≥ 9.0 g/dL, platelets (PLT) ≥ 100 × 10^9/L;
- •Liver function: Total bilirubin < 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5 × ULN;
- •Renal function: Serum creatinine < 1.5 × ULN.
- •Voluntary participation with signed informed consent form.
排除标准
- •History of other malignancies (except adequately treated non-melanoma skin cancer, in situ carcinoma, or other cancers cured ≥5 years prior);
- •Comorbidities requiring long-term immunosuppressive therapy or systemic/local corticosteroids at immunocompromising doses;
- •Immunodeficiency diseases or history of organ transplantation (including but not limited to: interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.);
- •HIV-positive status; HBsAg-positive with detectable HBV DNA ≥1000 copies/mL; or HCV antibody-positive;
- •High-dose glucocorticoid use within 4 weeks prior;
- •Pregnant/lactating women or individuals of reproductive potential without effective contraception;
- •Laboratory test abnormalities beyond protocol-defined thresholds within 7 days before enrollment;
- •Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function;
- •Uncontrolled comorbidities or active infections;
- •Concurrent participation in other clinical trials or receipt of investigational drugs;
- •Unwillingness or inability to provide written informed consent;
- •Other contraindications to study treatment;
- •Psychiatric disorders or cognitive impairment limiting legal competency.
研究组 & 干预措施
Experimental group
Iparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity，or for a maximum of one year
干预措施: Iparomlimab and Tuvonralimab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
次要结局
- 2-Year Progression-Free Survival Rate (PFS)(2-year)
研究者
Fei Han
Principal lnvestigator
Sun Yat-sen University