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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Biological: Camrelizumab; Drug: Cisplatin; Radiation: IMRT or VMAT

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yan Li, MD, PhD; Phone Number: 18980606806; Email: yy1240@163.com
• Study Contact Backup: Name: Xingchen Peng, MD,PhD; Phone Number: 18980606753; Email: pxx2014@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Investigational Arm; Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.

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.; Other Names: SHR-1210; 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.; Other Names: Platinol; Radiation: IMRT or VMAT; 66-70 Gy given in 33-35 fractions over 6-7 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is the time from randomization to death due to any cause.	Up to 5 years
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Yan Li, MD,PhD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Chemoradiation; Immune Checkpoint Inhibitors; Squamous Cell Carcinoma; Head and Neck
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: HP18-TCR-XN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No