Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC

• ClinicalTrials.gov Identifier: NCT04826679
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Sponsor: Sun Yat-sen University
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Xuekui Liu, Sun Yat-sen University

Tracking Information

• First Submitted Date: March 30, 2021
• First Posted Date: April 1, 2021
• Last Update Posted Date: April 1, 2021
• Estimated Study Start Date: April 1, 2021
• Estimated Primary Completion Date: April 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2021)

ORR [ Time Frame: 9 weeks ]

overall response rate

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 30, 2021)

• pCR [ Time Frame: 9 weeks ]
  Pathological Complete Response
• MPR [ Time Frame: 9 weeks ]
  Major Pathological Response
• DCR [ Time Frame: 9 weeks ]
  Disease Control Rate
• PFS [ Time Frame: 2 years ]
  Progression-free survival
• OS [ Time Frame: 5 years ]
  overall survival
• Adverse events graded by CTCAE v5.0 [ Time Frame: 90 days after the first dose of study treatment ]
  Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC
• Official Title: An Open Label, Single Arm Phase II Study of Camrelizumab in Combination With Cisplatin and Nab-paclitaxel as a Novel Neoadjuvant Pre-Surgical Therapy for Resectable HNSCC

Brief Summary

This study is a single arm phase II trial including 53 patients with T2N2-3M0、T3-4N0-3M0（III-IV） head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive neo-adjvuant Camrelizumab combined with cisplatin and Nab-paclitaxel.

This proposed study will evaluate the efficacy and safety of preoperative administration of Camrelizumab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.

• Detailed Description: In this study, eligible subject will be enrolled into study arm to accept study treatment. Objective response rate will be the primary outcome measures.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Head and Neck Squamous Cell Carcinoma

Intervention

Drug: Camrelizumab, nab-paclitaxel, cisplatin

Patients receive Camrelizumab IV on day 1, nab-paclitaxel IV on day 1 and cisplatin IV on day 1.

Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Other Name: Camrelizumab and chemotherapy

Study Arms

Experimental: Experimental

Camrelizumab + Cisplatin + Nab-paclitaxel

Camrelizumab (IV), dose= 200mg , day=1 , cycle length: 21 days. Cisplatin (IV), dose=60mg/m2, day= 1, cycle length: 21 days. Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.

Intervention: Drug: Camrelizumab, nab-paclitaxel, cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 30, 2021): 53
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2026
• Estimated Primary Completion Date: April 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria：

1. Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2N2-3M0、T3-4N0-3M0（III-IV）（AJCC 8.0）
2. Greater than or equal to 18 and less than 65 years of age at time of study entry.
3. ECOG performance status of 0 or 1.
4. Resectable or potentially resectable lesion, without distance metastasis;
5. Measurable disease as per RECIST 1.1.
6. Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
7. Adequate hepatic、cardiac、brain and renal function as demonstrated by 1) Hematology: WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL； 2) Renal: Serum creatinine < 1.5x ULN or CrCl > 60mL/min (if using the Cockcroft-Gault formula below): 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3 x ULN)；AST/ALT ≤ 3 x ULN and ALP≤3 x ULN；ALB≥3g / dL；
8. Ability to understand and willingness to sign an IRB approved written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

1. Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
2. Active, known or suspected autoimmune disease, including dementia and epilepsy.
3. Has had another known invasive malignancy or unresectable cancer.
4. Coagulation dysfunction: (PT > 16S, APTT > 53s, TT > 21s, FIB < 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
5. Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
6. Laboratory abnormality within 7 days before enrollment.
7. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
8. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
9. Has a known history of Human Immunodeficiency Virus (HIV).
10. Has a known history of Hepatitis B (defined as HBV DNA ≥1000 cps/mL is detected) or known active Hepatitis C virus (defined as: HCV antibody positive) infection.
11. have received anti-tumor herbs within 4 weeks before randomization.
12. Pregnant or nursing women.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: xuekui Liu; 13609713406; Liuxk@sysucc.org.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04826679
• Other Study ID Numbers: OBU-GD1-BC-HNC-II-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Xuekui Liu, Sun Yat-sen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Yat-sen University
• Original Study Sponsor: Same as current
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Investigators

• Principal Investigator: xuekui Liu; Sun Yat-sen University

• PRS Account: Sun Yat-sen University
• Verification Date: March 2021