Back to resultsA Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer
Primary Purpose
Head and Neck Neoplasms
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Camrelizumab
Cisplatin
IMRT or VMAT
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Head and Neck, Squamous Cell Carcinoma, Immune Checkpoint Inhibitors, Chemoradiation
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational Arm
Arm Description
Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.
Outcomes
Primary Outcome Measures
Objective Response Rate
The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
Secondary Outcome Measures
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Disease-free Survival (DFS)
DFS is the time from the date of randomization to the date of first record of disease recurrence or death.
Acute Adverse Events (AEs)
The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04405154
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Head and Neck, Squamous Cell Carcinoma, Immune Checkpoint Inhibitors, Chemoradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational Arm
Arm Type
Experimental
Arm Description
Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.
Intervention Type
Biological
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
SHR-1210
Intervention Description
Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
75-100 mg/m^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation.
Intervention Type
Radiation
Intervention Name(s)
IMRT or VMAT
Intervention Description
66-70 Gy given in 33-35 fractions over 6-7 weeks.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is the time from randomization to death due to any cause.
Time Frame
Up to 5 years
Title
Disease-free Survival (DFS)
Description
DFS is the time from the date of randomization to the date of first record of disease recurrence or death.
Time Frame
Up to 5 years
Title
Acute Adverse Events (AEs)
Description
The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Li, MD, PhD
Phone
18980606806
Email
yy1240@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xingchen Peng, MD,PhD
Phone
18980606753
Email
pxx2014@scu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Li, MD,PhD
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer
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