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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04405154
• Other study ID #: HP18-TCR-XN001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2020
• Source: West China Hospital
• Contact: Yan Li, MD, PhD
• Phone: 18980606806
• Email: yy1240[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Biological:
• Camrelizumab
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.

Drug:
• Cisplatin
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.

Radiation:
• IMRT or VMAT
66-70 Gy given in 33-35 fractions over 6-7 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1	6 months
Secondary	Overall Survival (OS)	OS is the time from randomization to death due to any cause.	Up to 5 years
Secondary	Disease-free Survival (DFS)	DFS is the time from the date of randomization to the date of first record of disease recurrence or death.	Up to 5 years
Secondary	Acute Adverse Events (AEs)	The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0	Up to 6 months