A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer

Sichuan University

Status and phase

Not yet enrolling

Phase 2

Conditions

Head and Neck Neoplasms

Treatments

Biological: Camrelizumab

Drug: Cisplatin

Radiation: IMRT or VMAT

Study type

Interventional

Funder types

Other

Identifiers

NCT04405154

HP18-TCR-XN001

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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
Has known history of Human Immunodeficiency Virus (HIV)
Has a significant cardiovascular disease
Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment
Has had previous allogeneic tissue/solid organ transplant
Has active infection requiring systemic therapy
Is pregnant or breast feeding