Study of TQB2450 in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck（R/M SCCHN）

NCT03855384 | Unknown Phase 3 DMC

• 1 other identifier: TQB2450-II-03
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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 enhancing immune response and has potential to treat various types of tumors.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival

  up to 72 weeks

Secondary Outcomes (3)

• DOR

  up to 72 weeks

• PFS

  up to 24 weeks

• DCR

  up to 24 weeks

Study Arms (2)

TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

EXPERIMENTAL

Drug: TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

PLACEBO COMPARATOR

Drug: placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

Interventions

TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) DRUG

TQB2450 1200mg IV ，cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).

TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU) DRUG

placebo 1200mg IV ，cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).

placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

Eligibility Criteria

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

You may qualify if:

• 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 .
• 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.

You may not qualify if:

• 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.
• \. 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.
• \. 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.
• \. 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.
• \. Has any other active infection requiring systemic therapy,including patients with active tuberculosis.
• \. 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.
• \. Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Carboplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ye Guo, doctor

CONTACT

021-38804518; pattrickguo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 26, 2019
• Study Start: June 11, 2019
• Primary Completion: December 31, 2020
• Study Completion: May 30, 2021
• Last Updated: October 30, 2019

Record last verified: 2019-02

Locations

CN (1)