Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First… (NCT07101744) | Clinical Trial Compass
RecruitingPhase 2
Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
China41 participantsStarted 2025-10-17
Plain-language summary
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
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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:
✓. Voluntary participation with signed informed consent form.
Exclusion criteria
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 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
. 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;