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New treatment option for Nasopharyngeal Carcinoma (NPC)
Official title Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
ClinicalTrials.gov ID: NCT07101744
What this study is testing
What is Iparomlimab and Tuvonralimab?
Iparomlimab and Tuvonralimab is an investigational medicine, being studied as a potential treatment for nasopharyngeal carcinoma (npc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Availability of nasopharyngeal + neck MRI data prior to enrollment, with at least one measurable lesion (excluding bone metastases);
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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...
- 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...
- Voluntary participation with signed informed consent form.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.