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

NCT04405154 | Unknown Phase 2

• 1 other identifier: HP18-TCR-XN001
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck; Squamous Cell Carcinoma; Immune Checkpoint Inhibitors; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1

  6 months

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 5 years

• Disease-free Survival (DFS)

  Up to 5 years

• Acute Adverse Events (AEs)

  Up to 6 months

Study Arms (1)

Investigational Arm

EXPERIMENTAL

Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.

Biological: Camrelizumab; Drug: Cisplatin; Radiation: IMRT or VMAT

Interventions

Camrelizumab BIOLOGICAL

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.

Also known as: SHR-1210

Investigational Arm

Cisplatin DRUG

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.

Also known as: Platinol

Investigational Arm

IMRT or VMAT RADIATION

66-70 Gy given in 33-35 fractions over 6-7 weeks.

Investigational Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

camrelizumab; Cisplatin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Yan Li, MD,PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Li, MD, PhD

CONTACT

18980606806; yy1240@163.com

Xingchen Peng, MD,PhD

CONTACT

18980606753; pxx2014@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: June 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2025
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share