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

NCT04857164 | Recruiting Phase 2

• 1 other identifier: KTP-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; immune therapy; Pembrolizumab combined with chemotherapy

Outcome Measures

Primary Outcomes (1)

• objective response rate(ORR)

  To evaluate the objective response rate of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma

  18 weeks

Secondary Outcomes (5)

• progression free survival(PFS)

  4 year

• disease control rate (DCR)

  4 year

• duration of response (DOR)

  4 year

• progression free survival rate(PFS rate)

  6 months and 12 months

• overall survival (OS)

  4 year

Other Outcomes (1)

• Tumor related biomarkers

  4 year

Study Arms (1)

Pembrolizumab combined with Chemotherapy

EXPERIMENTAL

Chemotherapy regimen\* is as follows, selected by the investigator, 3 weeks (21 days) is a cycle，combined with pembrolizumab 200 mg intravenously on day 1, every 21 days is a treatment cycle until the disease progresses or the toxicity cannot be tolerated(Less than or equal to 35 cycle) \*1) Cisplatin(75 mg/m2) + albumin-bound paclitaxel(260 mg/m2) 2)Cisplatin(25 mg/m2,d1-d3) + albumin-bound paclitaxel(260 mg/m2) 3)Carboplatin(AUC5) + Albumin-bound Paclitaxel(260 mg/m2)

Drug: Pembrolizumab combined with Chemotherapy

Interventions

Pembrolizumab combined with Chemotherapy DRUG

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

Also known as: keytruda and Chemotherapy

Pembrolizumab combined with Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign written informed consent before screening;
• Age 18\~75 years old;
• ECOG physical status score 0-1 points;
• Head squamous cell carcinoma (HNSCC) diagnosed by histology or cytology, the primary site is oral cavity, oral cavity Throat, lower throat or throat;
• 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, right For lesions that have received radiotherapy in the past, only if there is clear disease progression 3 months after the end of radiotherapy, can it be Was selected as the target lesion;
• There are a large number of tumor tissue samples for PD-L1 immunohistochemical detection;
• The expected survival period exceeds 3 months;
• The main organs function normally, that is, they meet the following standards:
• I. Blood routine (not receiving blood transfusion 14 months before screening examination, erythropoietin (EPO), granulocyte set Fall stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) treatment): neutral Granulocyte ≥1.5×l09
• L, platelets ≥100×109
• L, hemoglobin≥90g/L; ii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ 3 for those without liver metastasis ×ULN, ALT and AST for liver metastases≤5×ULN; total bilirubin (TBIL)≤1.5×ULN (Gilbert Syndrome patients, ≤3×ULN); iii. Renal function: Serum creatinine (Cr)≤1.5×ULN or tendon clearance (Ccr)≥50ml/min (connect Residues treated with carboplatin) or ≥60ml/min (residuals treated with cisplatin); iv. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), thrombin Original time (PT)≤1.5×ULN; v. Heart echocardiogram: left ventricular ejection fraction (LVEF) ≥50%;
• Women should agree to use contraceptive measures (such as intrauterine birth control) during the study period and within 6 months after the study ends.
• Device \[IUD\], contraceptive pill or condom); 7 diabetes blood pregnancy test was negative before study enrollment, and it must be non-Breastfeeding patients; males should agree to use contraceptive measures during the study period and within 6 months after the end of the study period patient.

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 treatment for locally advanced disease as a part of multimodal treatment Chemotherapy (the end of this treatment must be more than 6 months after the first trial medication); Note: Multimodal therapy 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 received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway;
• Other malignant tumors have occurred within 5 years or at the same time during the current period, except for cured cervical carcinoma in situ, non- Skin cancer of melanoma 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;
• With known active central nervous system metastasis (CNS) and/or cancerous meningitis: previous treatment Subjects with brain metastases treated for treatment can participate in the study, provided that they are clinically stable for at least 2 weeks and there are no new or enlarged brains.
• Evidence was transferred, and steroids were discontinued 14 days before study drug administration. The stable brain metastasis in this definition should be in Determine before the first administration of the study drug. Subjects with asymptomatic brain metastases (ie no neurological symptoms, no need Corticosteroids, and no lesions\> 1.5cm) can participate, but the brain needs to be regularly performed as a disease site Film degree exam;
• Did not recover from any acute effects of previous surgery, chemotherapy or radiotherapy, that is, did not fall to ≤1 grade (NCI CTCAEv5.0) subjects (except for hair loss). If the nutritional status is stable, allow previous radiotherapy and/or surgery Chronic late toxicity (pharyngeal/larynx toxicity, ie dry mouth, abnormal speech, swallowing, etc.);
• Any component of the studied drug or preparation has caused severe allergic reactions, including known Severe allergic reaction to Longan antibody (NCI CTCAEv5.0≥3);
• Have received anti-tumor drug treatment (such as chemotherapy, hormone therapy, immune Disease treatment, antibody treatment, radiotherapy, etc.), except for palliative radiotherapy for bones to relieve pain;
• Chinese herbal medicine or Chinese patent medicine receiving 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. The following conditions are excluded:

Sponsors & Collaborators

• Yuankai Shi: lead

Study Sites (1)

National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

Drug Therapy; pembrolizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

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: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Oncology, Chief physician

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: April 30, 2021
• Primary Completion: August 20, 2023
• Study Completion: January 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)