Clinical trial NCT04405154: A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer
Official title: A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Keywords: Head and Neck
Squamous Cell Carcinoma
Immune Checkpoint Inhibitors
Chemoradiation
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 6 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Disease-free Survival (DFS)
timeFrame: Up to 5 years
measure: Acute Adverse Events (AEs)
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Yan Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: