Study of Pembrolizumab in the First Line Therapy for R/M HNSCC in China

NCT04740996 | Unknown

• 1 other identifier: NCT123
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is main evaluate the efficacy and safety of pembrolizumab in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma with PD-L1 CPS≥20.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; immune therapy; Pembrolizumab

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  To evaluate the objective response rate (ORR, RECIST standard 1.1 evaluation) of pembrolizumab in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma with PDL1 CPS≥20

  1 year

• survival time (OS)

  To evaluate the survival time (OS) of pembrolizumab in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma with PDL1 CPS≥20

  1year

Secondary Outcomes (4)

• objective response rate(ORR)

  1 year

• disease control rate (DCR)

  1 year

• duration of response (DOR)

  1 year

• progression-free survival (PFS, PFS2)

  1 year

Other Outcomes (1)

• TMB, T cell gene expression

  3 year

Interventions

Pembrolizumab DRUG

Pembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer.

Also known as: keytruda

Eligibility Criteria

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

Study Population

Patients with recurrent and/or metastatic head and neck squamous cell carcinoma who are about to receive advanced first-line treatment.

You may qualify if:

• Voluntarily sign a written informed consent before screening;
• Male or female, aged ≥18 years old;
• ECOG physical status score 0-1 points;
• Head and neck squamous cell carcinoma (HNSCC) confirmed by histology or cytology, the primary site is oral cavity, oropharynx, hypopharynx or larynx;
• Recurrent and/or metastatic HNSCC without indications for local radical treatment;
• According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one measurable lesion. For lesions that have received radiotherapy in the past, they can only be selected as the disease if there is a clear disease progression 3 months after the end of radiotherapy. Target lesion
• PD-L1 immunohistochemical detection of tumor tissue samples with CPS≥20;
• The expected survival period exceeds 3 months;
• The main organs function normally, that is, they meet the following standards:
• i. Routine blood test (not receiving blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) within 14 days before the screening examination) : Neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90g/L; ii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST≤3×ULN for those without liver metastasis, ALT and AST≤5×ULN for those with liver metastasis; total bilirubin (TBIL)≤ 1.5×ULN (Patients with Gilbert syndrome, ≤3×ULN); iii. Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥50ml/min; iv. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN;
• Heart echocardiogram: left ventricular ejection fraction (LVEF) ≥50%;
• Women should agree to use contraceptive measures (such as intrauterine device \[IUD\], contraceptives or condoms) during the study period and 6 months after the end of the study; the blood pregnancy test is negative within 7 days before the study is enrolled, And must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

You may not qualify if:

• Patients who are suitable for local treatment and are willing to local treatment;
• Have received systemic chemotherapy, but does not include chemotherapy for locally advanced disease as a part of multimodal treatment (the end of this treatment must be more than 6 months from the first trial drug); Note: Multimodal treatment includes induction chemotherapy, concurrent radiotherapy and chemotherapy and adjuvant chemotherapy.
• Locally advanced head and neck squamous cell carcinoma multimodal treatment is completed within 6 months of disease progression;
• Have previously been immunized with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies or drugs that target T cell co-stimulation or immune checkpoint pathways treatment;
• Other malignant tumors occurred within 5 years or at the same time during the current period, except for cured cervical carcinoma in situ, non-melanoma skin cancer, or other tumors/cancers that have undergone radical treatment and have no signs of disease for at least 5 years;
• Received cetuximab treatment within 6 months before the first administration;
• According to the standard of common adverse event term (NCI CTCAEv5.0), peripheral neuropathy has been ≥2 grade;
• Accompanied by known active central nervous system metastasis (CNS) and/or cancerous meningitis: Subjects with brain metastases who have received previous treatment can participate in the study, provided that they are clinically stable for at least 2 weeks and there are no new or expanded ones Evidence of brain metastases, and steroids were stopped 14 days before study drug administration. Stable brain metastases in this definition should be determined before the first administration of the study drug. Subjects with asymptomatic brain metastases (that is, no neurological symptoms, no corticosteroids, and no lesions\> 1.5 cm) can participate, but they need to have regular brain imaging examinations as the disease site;
• Subjects who have not recovered from any acute effects of previous surgery, chemotherapy or radiotherapy, that is, subjects who have not fallen to ≤1 (NCI CTCAEv5.0) (except for hair loss). If the nutritional status is stable, allow the chronic late toxicity (pharyngeal/laryngo toxicity, dry mouth, abnormal speech, swallowing, etc.) from previous radiotherapy and/or surgery;
• Any component of the studied drug or preparation has caused severe allergic reactions, including known severe allergic reactions to other monoclonal antibodies (NCI CTCAEv5.0≥3);
• Have received anti-tumor drug therapy (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) 4 weeks or 4 weeks before the first administration, except for palliative radiotherapy for bones to relieve pain;
• Chinese herbal medicines or proprietary Chinese medicines that have received anti-tumor treatment ≤1 week before the first administration;
• Have received major surgery within 4 weeks before the first administration or are expected to undergo major surgery during the study period;
• Immunosuppressive drugs need to be used 2 weeks before the first administration or within 2 weeks or during the study period, except for the following conditions:
• Intranasal, inhaled, topical steroid or topical steroid injection (such as intra-articular injection);

Sponsors & Collaborators

• Shi Yuankai: lead

Study Sites (1)

Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuankai Shi, MD

  Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, MD

CONTACT

+86-10-87788293; syuankaipumc@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Oncology, Chief physician

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: February 4, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)