Combining EGFR antibody, PD-1 inhibitor, and chemotherapy for advanced nasopharyngeal carcinoma

EGFR Antibody Combined With Programmed Death-1 Inhibitor and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Multi-center, Phase I/II Clinical Trial

This study tests a new combination of treatments using an EGFR antibody, a PD-1 inhibitor, and chemotherapy to see if it helps people with advanced nasopharyngeal carcinoma feel better compared to standard options.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06802835 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a combination treatment involving an EGFR antibody, a PD-1 inhibitor, and chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma. It is a prospective, single-arm study that aims to assess how well this combination works compared to standard treatments. Participants will receive the treatment and be monitored for both efficacy and adverse effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with recurrent or metastatic nasopharyngeal carcinoma who have not received prior anti-tumor therapies.

Not a fit: Patients who have previously undergone any form of anti-tumor therapy for their recurrence or metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in various cancers, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with nasopharyngeal carcinoma who have recurred/metastasized after initial treatment or radical treatment;
* Age 18-75, male or female;
* Pathological diagnosis of nasopharyngeal carcinoma;
* ECOG score 0-1;
* Have not previously received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biotherapy for recurrence/metastasis;
* No contraindications of chemotherapy, immunotherapy and targeted therapy;
* At least 1 measurable lesion that meets RECIST 1.1 criteria;
* Blood routine examination standards should meet: WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L, HGB≥90g/L (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct);
* Biochemical tests should meet the following criteria: TBIL≤2.0×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance ≥60ml/min (Cockcroft-Gault formula);
* Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the intended range of anticoagulant drug use;
* The myocardial enzyme spectra were in the normal range;
* Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days of enrollment with a negative result and be willing to use an effective method of contraception during the trial and for 3 months after the last anti-PD-1 antibody administration. For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial and within 3 months after the last anti-PD-1 antibody administration;
* The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;

Exclusion Criteria:

* Patients with recurrence who can be treated with local resection or radiotherapy;
* Known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies;
* Patients have symptoms of central nervous system metastasis such as brain edema and need hormonal intervention;
* Had an active infection or unexplained fever \>38.5℃ during screening or prior to the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled);
* Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[may be included after normal hormone replacement therapy\]); Patients with vitiligo or complete remission of asthma in childhood without any intervention as adults could be included, but patients with asthma requiring medical intervention with bronchodilators could not be included;
* Have congenital or acquired immunodeficiency (such as HIV), active hepatitis B (HBV-DNA≥103 copy number /ml), or hepatitis C (hepatitis C antibody positive and HCR-RNA above the lower detection limit of analytical methods);
* Previous or co-existing uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer;
* Uncontrolled cardiovascular disease: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); Patients with grade III-IV cardiac insufficiency according to NYHA standards, or left ventricular ejection fraction (LVEF) \<50% indicated by cardiac color ultrasound; Myocardial infarction within 1 year;
* If the subject has undergone major surgery, the toxic effects and/or complications of the surgical intervention must be fully recovered before treatment is initiated;
* Within 4 weeks prior to the first use of the investigational drug (participants in the follow-up period are counted as the last use of the investigational drug or device) or are currently participating in another clinical study;
* Live vaccine received within 4 weeks prior to the first administration of the investigational drug is allowed to receive inactivated virus vaccine for seasonal influenza by injection, but not live attenuated influenza vaccine for nasal administration;
* Pregnant or lactating women;
* In the investigator's judgment, the subjects had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the safety of the subjects or the circumstances of the trial data collection.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhao Chong PhD.

Conditions Nasopharyngeal Cancinoma; Recurrent Nasopharynx Carcinoma; Metastatic Nasopharyngeal Carcinoma; EGFR antibody; PD-1 antibody; chemotherapy