Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002)

NCT05098119 | Recruiting Phase 2

• 1 other identifier: 006
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy and safety of sintilimab in combination with reduction of cycles of chemotherapy (carboplatin and nab-paclitaxel) in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in oral cavity or oropharyngeal squamous cell carcinoma.

Conditions

Oral Cavity Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• pTR-2

  pTR（pathologic tumor response）was quantified as the proportion of the resection bed with tumor necrosis, keratinous debris, and giant cells/histiocytes: pTR-0 (\<10%), pTR-1 (10-49%), and pTR-2 (≥ 50%).

  At time of surgery

Secondary Outcomes (5)

• Adverse events graded by CTCAE v5.0

  [Time Frame: 90 days after the first dose of study treatment]

• Disease-free survival （DFS）

  2 years

• Overall survival（OS）

  5 years

• Radiographic Response

  5 weeks

• Rate of surgery delay

  8 weeks after the patient receives their treatment

Study Arms (1)

Sintilimab+ Carboplatin + Nab-paclitaxel

EXPERIMENTAL

Neoadjuvant therapy (the total cycles of the treatment is 3) ： Cycle1（Cycle length: 21 days）： Sintilimab (IV), dose= 200mg, day=1; Carboplatin (IV), dose=300mg/m2, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1. Cycle2、3（Cycle length: 21 days）： Sintilimab (IV), dose= 200mg, day=1. Adjuvant therapy（will be dictated by surgical pathology and occurs after standard of care surgery）： Sintilimab will be given intravenously once every 3 weeks for up to 1 year if participant is considered high-risk based on surgical pathology（high risk features：positive margins or extracapsular extension). These doses of Sintilimab will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.

Drug: Sintilimab, Nab-paclitaxel, Carboplatin; Procedure: Surgical resection; Drug: Sintilimab

Interventions

Sintilimab, Nab-paclitaxel, Carboplatin DRUG

Neoadjuvant Therapy

Sintilimab+ Carboplatin + Nab-paclitaxel

Surgical resection PROCEDURE

Standard of care

Sintilimab+ Carboplatin + Nab-paclitaxel

Sintilimab DRUG

Adjuvant Therapy

Sintilimab+ Carboplatin + Nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a histologically confirmed diagnosis of OSCC or OPSCC which is planned for treatment with curative intent including surgical resection.
• Greater than or equal to 18 and less than 80 years of age at time of study entry.
• ECOG performance status of 0 or 1.
• Measurable disease as per RECIST 1.1.
• Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines.
• Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
• Adequate hepatic and renal function as demonstrated by
• Serum creatinine \< 1.5 X ULN or CrCl \> 40mL/min (if using the Cockcroft-Gault formula below):
• Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)）
• Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))x 0.85
• AST/ALT ≤ 3 x ULN
• Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
• Adequate bone marrow function as demonstrated by:
• Absolute Neutrophil Count \>1,500/µL
• Platelets \> 100 X 103/µL

You may not qualify if:

• Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.
• If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
• Active, known or suspected autoimmune disease. Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger .
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.
• 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 costimulation or immune checkpoint pathways.
• A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
• Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
• Has known active Hepatitis B or C.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

sintilimab; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Song Fan, Doctor degrees

CONTACT

020-81332220; fansong2@mail.asysu.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: Associate Professor

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 28, 2021
• Study Start: September 16, 2021
• Primary Completion: September 16, 2024
• Study Completion (Estimated): September 16, 2028
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

CN (1)