A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma

West China Hospital0 sites32 target enrollmentJune 1, 2020

ConditionsHead and Neck Neoplasms

InterventionsCamrelizumab Cisplatin IMRT or VMAT

DrugsCisplatin

Overview

Phase: Phase 2
Intervention: Camrelizumab
Conditions: Head and Neck Neoplasms
Sponsor: West China Hospital
Enrollment: 32
Primary Endpoint: Objective Response Rate
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

May 31, 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

West China Hospital

Responsible Party

Principal Investigator

Yan Li

MD, PhD

West China Hospital

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Has a pathologically proven new diagnosis of head and neck squamous cell carcinoma
•Has unresectable disease and is eligible for definitive chemoradiation based on investigator decision
•Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on RECIST version 1.1
•Has adequate organ function as defined
•Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
•Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy

Exclusion Criteria

•Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
•Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
•Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
•Has a history of severe hypersensitivity reaction to camrelizumab, Cisplatin or radiotherapy
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
•Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or has previously participated in clinical studies with camrelizumab
•Has received a live vaccine within 30 days prior to the first dose of study therapy
•Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
•Has not recovered from major surgery prior to starting study therapy
•Has known active Hepatitis B or C