Iparomlimab and Tuvonralimab plus nimotuzumab for recurrent or metastatic nasopharyngeal carcinoma after first-line treatment failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase IIa trial testing a three-drug regimen (iparomlimab, tuvonralimab, and nimotuzumab) in patients with recurrent or metastatic nasopharyngeal carcinoma after failure of first-line cisplatin-based therapy. Eligible participants are adults 18–70 with ECOG 0–1, measurable lesions on MRI (excluding bone-only disease), and available tumor tissue for PD-L1 testing. The primary focus is preliminary efficacy and safety to generate evidence on whether the combination yields meaningful tumor responses and an acceptable safety profile. The trial is conducted at Sun Yat-sen University Cancer Center and is intended as an exploratory step toward larger, controlled studies if results are promising.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ECOG performance status score of 0-1;
2. Age 18 to 70 years;
3. Histologically confirmed nasopharyngeal carcinoma;
4. 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);
5. Availability of nasopharyngeal + neck MRI data prior to enrollment, with at least one measurable lesion (excluding bone metastases);
6. Willingness to provide archived tumor tissue specimens or undergo a biopsy to collect tumor tissue for PD-L1 expression level testing;
7. 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.
8. Voluntary participation with signed informed consent form.

Exclusion Criteria:

1. History of other malignancies (except adequately treated non-melanoma skin cancer, in situ carcinoma, or other cancers cured ≥5 years prior);
2. Comorbidities requiring long-term immunosuppressive therapy or systemic/local corticosteroids at immunocompromising doses;
3. Immunodeficiency diseases or history of organ transplantation (including but not limited to: interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.);
4. HIV-positive status; HBsAg-positive with detectable HBV DNA ≥1000 copies/mL; or HCV antibody-positive;
5. High-dose glucocorticoid use within 4 weeks prior;
6. Pregnant/lactating women or individuals of reproductive potential without effective contraception;
7. Laboratory test abnormalities beyond protocol-defined thresholds within 7 days before enrollment;
8. Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function;
9. Uncontrolled comorbidities or active infections;
10. Concurrent participation in other clinical trials or receipt of investigational drugs;
11. Unwillingness or inability to provide written informed consent;
12. Other contraindications to study treatment;
13. Psychiatric disorders or cognitive impairment limiting legal competency.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangdong, China Recruiting

Study contacts

• Study coordinator: hui xiao wang, Ph.D. (Doctor of Philosophy)
• Email: wangxh@sysucc.org.cn
• Phone: 86+18826260661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.