Iparomlimab and Tuvonralimab Injection for Untreated Locally Advanced Nasopharyngeal Carcinoma

NCT07135804 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT-I-2025-001
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter phase II clinical study. The subjects are patients with previously untreated locally advanced nasopharyngeal carcinoma, with clinical staging of IVA, T1-4, N3, M0. The study aims to preliminarily evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injectionin the treatment of these patients.

Conditions

Locally Advanced Nasopharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 3-year distant metastasis-free survival (DMFS) as assessed by imaging examinations (including CT, MRI, PET-CT) and clinical evaluations to determine the time from randomization to the first occurrence of distant metastasis or death from any cause

  DMFS will be calculated as the time from the date of enrollment to the date of first documented distant metastasis (confirmed by imaging modalities such as CT, MRI, or PET-CT) or death from any cause, whichever occurs earlier. Patients who are lost to follow-up or withdraw from the study will be censored at the last date they were known to be free of distant metastasis and alive. The 3-year DMFS rate will be estimated using the Kaplan-Meier method, with the 95% confidence interval reported.

  Up to 3 years after enrollment (each follow-up cycle is 3 months for the first two years, 6 months for the third year)

• Objective response rate (ORR) of the tumor as assessed by RECIST 1.1 criteria, including complete response (CR) and partial response (PR) confirmed by imaging examinations (CT, MRI)

  ORR is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR is defined as the disappearance of all target lesions and no new lesions, with normalization of tumor marker levels if applicable. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters. Responses must be confirmed by a subsequent assessment at least 4 weeks after the initial documentation of CR or PR

  Every 9 weeks during treatment (each treatment cycle is 3 weeks) and at the end of treatment

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Eligible subjects are selected according to the inclusion and exclusion criteria. They will receive 3 courses of Iparomlimab and Tuvonralimab Injection during the induction chemotherapy period, undergo standard concurrent chemoradiotherapy as scheduled, and receive 9 cycles of Iparomlimab and Tuvonralimab Injection (5mg/kg, Q3W) in the adjuvant stage. This will continue until the researcher judges that the subject can no longer benefit, the disease progresses, intolerable toxicity occurs, the researcher decides to stop, the subject withdraws informed consent, or death occurs.

Drug: Iparomlimab and Tuvonralimab Injection

Interventions

Iparomlimab and Tuvonralimab Injection DRUG

Patients will receive Iparomlimab and Tuvonralimab Injection on the basis of 3 cycles of induction chemotherapy, followed by standard concurrent chemoradiotherapy, and then 9 cycles of Iparomlimab and Tuvonralimab Injection as adjuvant therapy

Also known as: QL1706

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have fully understood the study and voluntarily signed the informed consent form
• Newly diagnosed and histologically confirmed nasopharyngeal non-keratinizing carcinoma (T1-4, N3, M0, Stage IVA) with no evidence of distant metastatic disease
• Induction chemotherapy regimen: gemcitabine plus cisplatin; radiotherapy prescription dose is 70Gy, with 32-35 fractions, single dose of 2.0-2.2Gy, to be completed within 7 weeks (once a day, 5 times a week); concurrent cisplatin 80mg/m² during radiotherapy
• According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), have at least one measurable lesion (except for brain metastases)
• ECOG performance status of 0-1
• Male or female patients aged 18-70 years
• Estimated survival time ≥ 3 months
• Laboratory test values within 7 days before enrollment must meet the following standards (no blood components, cell growth factors, albumin or other corrective treatment drugs are allowed within 14 days before obtaining laboratory tests):
• Absolute neutrophil count (ANC) ≥ 1.5×10⁹ /L;
• Platelets ≥ 100×10⁹ /L;
• Hemoglobin ≥ 9g/dL;
• Serum albumin ≥ 2.8g/dL;
• Total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; if there is liver metastasis, ALT and/or AST ≤ 5×ULN; if there is liver metastasis or bone metastasis, AKP ≤ 5×ULN;
• Serum creatinine ≤ 1.5×ULN or creatinine clearance rate \> 60 mL/min (Cockcroft-Gault, see Appendix II);
• Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (screening is allowed for those receiving stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants)

You may not qualify if:

• Received anti-tumor cytotoxic drug therapy, biological drug therapy (such as monoclonal antibodies), immunotherapy (such as interleukin-2 or interferon), or other investigational drug therapy within 4 weeks before enrollment, except for corticosteroids
• Previously received anti-VEGFR and other vascular-targeted drug therapy
• Judged by the researcher to have impaired immunity
• Underwent major surgical operation within 4 weeks before enrollment or has not fully recovered from previous surgery (the definition of major surgical operation refers to grade 3 and 4 operations specified in the "Administrative Measures for Clinical Application of Medical Technologies" implemented on May 1, 2009)
• Toxic reactions from previous anti-tumor treatment have not recovered to CTCAE grade 0-1, except for the following situations:
• Alopecia;
• Pigmentation;
• Peripheral neurotoxicity has recovered to \< CTCAE grade 2;
• Long-term toxicity caused by radiotherapy, which cannot recover as judged by the researcher
• Grade 3-4 bleeding or high bleeding risk caused by underlying malignant tumors (such as but not limited to tumors surrounding or infiltrating large blood vessels, i.e., carotid artery, jugular vein) and/or specific other high-risk characteristics (e.g., arteriovenous fistula)
• Previously or currently suffering from other malignant tumors (except for well-controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years)
• Subjects with any active autoimmune disease or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has been completely relieved in childhood and do not require any intervention in adulthood can be included; those with asthma requiring medical intervention with bronchodilators cannot be included)
• Previously used anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathways)
• Subjects with active pulmonary tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening
• Received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2031
• Last Updated: August 22, 2025

Record last verified: 2025-07