A Prospective Study of Pembrolizumab Combined with Chemotherapy (cisplatin or Carboplatin + Albumin-bound Paclitaxel) in First-line Therapy for Patients with Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Yuankai Shi1 site in 1 country150 target enrollmentApril 30, 2021

ConditionsHead and Neck Squamous Cell Carcinoma

InterventionsPembrolizumab combined with Chemotherapy

DrugsPembrolizumab combined with Chemotherapy

Overview

Phase: Phase 2
Intervention: Pembrolizumab combined with Chemotherapy
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Yuankai Shi
Enrollment: 150
Locations: 1
Primary Endpoint: objective response rate(ORR)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Detailed Description

This trial is a single-center, prospective phase II clinical study, which mainly evaluates the efficacy and safety of first-line treatment with pembrolizumab combined with chemotherapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma

Registry

clinicaltrials.gov

Start Date

April 30, 2021

End Date

January 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yuankai Shi

Responsible Party

Sponsor Investigator

Principal Investigator

Yuankai Shi

Director, Head of Oncology, Chief physician

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.);

Arms & Interventions

Pembrolizumab combined with Chemotherapy

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)

Intervention: Pembrolizumab combined with Chemotherapy

Outcomes

Primary Outcomes

objective response rate(ORR)

Time Frame: 18 weeks

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