Status:
UNKNOWN
A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer
Lead Sponsor:
West China Hospital
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04405154
Start Date
June 1 2020
End Date
May 31 2025
Last Update
May 28 2020
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