Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma

NCT05578170 | Unknown DMC FDA Drug

• 1 other identifier: NFEC-2022-082
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective, single-center, single-arm, open-label II phase observation clinical trial is to evaluate the efficacy and safety of Pembrolizumab immunoadjuvant therapy in patients with stage III-IVA oral squamous cell carcinoma. The primary end point is the pathological tumor remission rate of the primary tumor and regional lymph nodes after neoadjuvant immunotherapy (pTR-2: the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections \> 50%). The secondary endpoints are 1-year disease-free survival (DFS), 1-year overall survival (OS) and the incidence of adverse events, compared with historical data. In addition, we will check the relevant immune indicators, such as PD-L1 and CPS scores.

Conditions

Oral Cavity Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of pathologic tumor response-2（pTR-2）

  The proportion of participants with a pathologic tumor response-2（pTR-2）as assessed by the Central Pathologist at the time of definitive surgery. pTR-2 is defined as the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections \> 50%

  Up to 30 days post-sugery

Secondary Outcomes (3)

• Disease-free Survival (DFS)

  Up to 1 year

• Overall Survival (OS)

  Up to 1 year

• Adverse Events (AEs)

  From time of first dose of study treatment until the end of follow-up (up to 1 year)

Study Arms (1)

Pembro Neoadjuvant + SOC Adjuvant

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Participants receive 200 mg pembrolizumab as a neoadjuvant by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles before surgery.

Pembro Neoadjuvant + SOC Adjuvant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage III-IVA oral squamous cell carcinoma.(See Eligibility Criteria)

You may qualify if:

• Age 18-70
• Male and female
• Patients histologically or cytologically difined as oral cavity squamous cell carcinoma
• According to the American Joint Committee on Cancer ( AJCC 8th Edition ) , patients with resectable stage III-IVA OCSCC
• ECOG performance status ≤ 1
• Patients with normal bone marrow and organ function as defined below:
• Blood routine examination:
• Absolute neutrophil count ≥ 1.5×109/L;
• Platelets ≥ 100.0×109/L;
• Hemoglobin ≥ 9.0 g/dL.
• Liver function:
• Totle bilirubin ≤ 2.0×ULN(Upper Limit Of Normal);
• Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase
• ×ULN;
• Albumin ≥ 2.8g/dL.

You may not qualify if:

• Prior treatment for OCSCC (sugery, immunotherapy, radiotherapy, chemotherapy)
• Patients with metastatic OCSCC with an unknown primary tumor site
• Patients with infectious disease: AIDS, hepatitis, active tuberculosis
• Received a live vaccine within 30 days prior to the first dose of pembrolizumab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin ( BCG ), typhoid vaccine, or attenuated flu vaccine
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
• Currently receiving any other investigational agents
• Has a history of allergic reactions attributed to compounds of similar chemical of biologic composition to pembrolizumab or other agents used in the study
• Patients with ongoing or active infectoin requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements
• Has a or more active autoimmune disease
• Has a history( non-infectious ) pneumonitis that required steroids or current pneumonitis

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Liuxiqiang

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine，Chief Physician

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 13, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)