Clinical trial NCT05673577: Camrelizumab in Combination With Cetuximab and Chemotherapy for Relapsed/Metastatic HNSCC Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Chemo-naive HNSCC
PD-1 inhibitor
cetuximab
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of camrelizumab in combination with cetuximab and chemotherapy as first-line for patients with relapsed/metastastic head and neck squamous cell carcinoma

Detailed description: Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative-intent therapies have poor survival.

At present, the standard treatment is cetuximab and chemotherapy plus PD-1 inhibitor Regimen.

This study is a phase II, prospective, single arm，single-center study, which requires a total of 40 R/M HNSCC patients. Patients will receive no more than 6 cycles of albumin paclitaxel and cisplatin, repeated every 3 weeks. PD-1 inhibitor will be administered until progression every 3 weeks. Cetuximab will be administered 400 mg/m2 at first dose, following by 250 mg/m2 after first dose until progression, repeated every 3 weeks.

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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2 years after enrollment of final patient
Secondary outcomes:
measure: Adverse events
timeFrame: Since the signing of informed consent forms to 30 days after the last cycle
measure: Progression-free Survival (PFS)
timeFrame: up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University
Study officials:
affiliation: Fudan University
name: Dongmei Ji, doctor
role: PRINCIPAL_INVESTIGATOR
References: