Status:
UNKNOWN
Study of TQB2450 in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck（R/M SCCHN）
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus e...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed head and neck squamous cell carcinoma ，primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx.
- No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.
- At least one measurable lesion（ based on RECIST1.1）.
- Can provide tissue for PD-L1 biomarker analysis: A newly obtained biopsy is preferred but an archival sample is acceptable.
- Tumors express PD-L1,and PD-L1 expression on at least 1% of tumour cells .
- 18 years and older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 3 months.
- The main organs function are normally, the following criteria are met:
- routine blood tests：hemoglobin（Hb）≥90g/L（no blood transfusion and blood products within 14 days）；absolute neutrophil count（ANC）≥1.5×109/L； platelets（PLT）≥100×109/L.
- Blood biochemical examination: alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)（when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ）； total bilirubin (TBIL)≤1.5×upper limit of normal (ULN)（Gilbert syndrome patients，≤3×upper limit of normal (ULN)）； calculated creatinine clearance（CrCl）≥60mL/min（Creatinine clearance criteria for subjects treated with cisplatin）or CrCl≥50mL/min（Creatinine clearance criteria for subjects treated with carboplatin）(Application of Standard Cockcroft-Gault Formula).
- Coagulation function: activated partial thromboplastin time (aPTT) 、 international normalized ratio (INR) 、prothrombin time（PT）≤ 1.5×upper limit of normal (ULN).
- left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography greater than or equal to 50%.
- Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study(Such as intrauterine devices , birth control pills or condoms) ；Not Pregnant or breastfeeding women,Pregnancy before pregnancy screening（Within 7 days before the start of the study）, the women who blood / urine results were positive.
- Understood and signed an informed consent form.
Exclusion
- Received systemic chemotherapy, but not chemotherapy for locally advanced disease as part of multimodality therapy (this treatment must be completed more than 6 months after informed consent).
- Has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Patients who have received cetuximab treatment within 6 moths before randomization.
- Diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、intramucosal carcinoma of gastrointestinal tract、breast and non-melanoma skin cancers and superficial bladder tumors.
- Known untreated central nervous system (CNS) metastasis and/or carcinomatous meningitis. 7. Has neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria.
- 8\. Previously had a severe hypersensitivity reaction to treatment with study drug or has a known sensitivity to any component of drug , including Severe hypersensitivity reaction≥3 grades (NCI CTCAEv5.0 )to monoclonal antibody 、fluorouracil、 carboplatin or cisplatin-related compounds.
- 9\. Active autoimmune disease that may worsen with the administration of an immunostimulant. Patients with type 1 diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism that do not require immunosuppression therapy are excluded.
- 10\. Immunosuppressive drugs were used at randomization,except that:
- Intranasal, inhaled, topical steroid or topical steroid injection (e.g. intra-articular injection)
- Physiological doses of systemic corticosteroids (a dose of ≤ 10 mg daily prednisone (or equivalent) )
- Preadministration of steroids for hypersensitivity reactions (e.g., preadministration of CT scans)" 11. Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension,acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis.
- 12\. Has any other active infection requiring systemic therapy,including patients with active tuberculosis.
- 13\. Unstable pleural effusion, pericardial effusion or ascites. 14. Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina.
- 15\. Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history.
- 16\. Virological examination of hepatitis B or hepatitis C during screening meets any of the following criteria:
- a. HBsAg positive and HBV DNA positive (≥1000 copies /mL); b. HCV antibody and HCV-RNA positive(The result is greater than the detection limit of the analytical method).
- 17\. Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks before randomization.
- Has received a live-virus vaccination within 4 weeks before randomization ,allowing received seasonal flu vaccines without live viruses.
- 19\. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
- 20\. Investigator judges that the patient is not eligible to join the study.
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT03855384
Start Date
June 11 2019
End Date
May 30 2021
Last Update
October 30 2019
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China