Combination treatment for advanced head and neck cancer

A Phase II Study of Camrelizumab in Combination With Cetuximab and Chemotherapy as First-line Therapy for Patients With Relapsed/Metastatic Squamous Cell Carcinoma of Head and Neck

This study is testing a new combination of drugs to see if it can help people with advanced head and neck cancer who haven't had chemotherapy before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: camrelizumab, cetuximab, chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT05673577 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the safety and efficacy of camrelizumab combined with cetuximab and chemotherapy in patients with relapsed or metastatic head and neck squamous cell carcinoma (HNSCC). The study aims to enroll 40 patients who have not previously received systemic chemotherapy and are not candidates for curative treatments. Participants will undergo a regimen of chemotherapy and PD-1 inhibitor therapy, with treatment cycles repeated every three weeks. The goal is to assess the effectiveness of this combination therapy as a first-line treatment option.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with recurrent or metastatic HNSCC who have not received prior systemic chemotherapy.

Not a fit: Patients with curable disease or those who have previously received systemic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced HNSCC.

How similar studies have performed: Other studies have shown promising results with similar combinations of PD-1 inhibitors and chemotherapy in treating advanced cancers.

Eligibility criteria

Main inclusion Criteria:

1. Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC.
2. Patients with distant metastases, or patients with local recurrence who are not suitable for local radical therapy, must have previously received radiotherapy (postoperative radiotherapy or radical radiotherapy) for local recurrence and must have ended radiotherapy more than 6 months ago.
3. Patients who have not received systemic chemotherapy before and who have received systemic chemotherapy as part of multidisciplinary treatment 6 months ago for locally advanced disease can be enrolled.
4. Age 18-70 years old.
5. ECOG performance status 0-1.
6. Patients must have at least one lesion that can be evaluated by enhanced CT or MRI according to Recist v1.1.
7. Hematopoietic function of bone marrow is basically normal: WBC ≥ 3.5 × 109/L, ANC ≥ 1.5 × 109/L, PLT ≥ 80 × 109/L, Hb ≥ 90 g/L.
8. Liver and kidney functions are basically normal: total bilirubin, ALT and AST are all\<1.5 × UNL (upper limit of normal value); Cr \< 1.5 × UNL, and creatinine clearance ≥ 50 ml/min.
9. Patients must have a life expectancy of at least 3 months.
10. Patients volunteered to sign informed consent.

Main exclusion Criteria:

1. Patients with a known history of severe allergy to monoclonal antibody therapy.
2. Patients with previous camrelizumab therapy or previous cetuximab therapy (cetuximab as part of therapy in multidisciplinary therapy for curative purposes may be included).
3. Patients with clinically significant heart disease, including severe cardiac insufficiency: New York College of Cardiology (NYHA) Grade IV cardiac insufficiency, unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, Q-Tc interval greater than 500ms.
4. Patients who had received secondary or higher gardes surgery within 3 weeks prior to treatment.
5. Patients suffering from autoimmune disease requiring treatment, or syndrome history requiring systemic use of steroids/immunosuppressants, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.
6. Other serious and uncontrollable concomitant diseases that may affect the compliance of the scheme or interfere with the interpretation of the results, including uncontrollable diabetes, or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm history).
7. Patients have evidence of central nervous system disease.
8. Patients with known hepatitis B (HBV) (HBsAg positive and HBV DNA ≥ 103IU/ml) and hepatitis C (HCV) infection (HCV antibody positive and HCV RNA detectable); And other subjects with acquired and congenital immunodeficiency diseases, including but not limited to those infected with AIDS virus.
9. Pregnant or lactating woman.
10. Patients have serious active infection.
11. Patients have a history of serious neurological or psychiatric diseases, including dementia or epilepsy.
12. Patients may interfere with the drug abuse, medical, psychological or social conditions of the subject involved in the study or the evaluation of the study results.
13. Patients considered unsuitable by the investigator.

Where this trial is running

Shanghai

• Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Dongmei Ji, doctor — Fudan University
• Study coordinator: Dongmei Ji, Doctor

Conditions Squamous Cell Carcinoma of Head and Neck; Chemo-naive HNSCC; PD-1 inhibitor; cetuximab