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Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial

ConditionsNasopharyngeal Carcinoma (NPC)First-line Treatment Failure Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab

    Drug

    Iparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity.

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

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

Time frame
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

Secondary outcomes

1

2-Year Progression-Free Survival Rate (PFS)

2-year failure free survival time from the randomization to the first treatment failure or death

Time frame
2-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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