Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas

NCT06109207 | Recruiting Phase 1

• 1 other identifier: 2023-1551
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death protein 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable head and neck squamous cell carcinoma(HNSCC).

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Squamous Cell Carcinoma; Neoadjuvant therapy; Immunotherapy; CDK4/6 inhibitor

Outcome Measures

Primary Outcomes (2)

• Safety of combination camrelizumab and dalpiciclib as assessed by number of participants who experience adverse events

  Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

  Through the study completion, an average of 12 weeks

• Feasibility of combination camrelizumab and dalpiciclib as assessed by number of participants who experience adverse events

  Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

  Through the study completion, an average of 12 weeks

Secondary Outcomes (5)

• Maximum Tolerated Dose (MTD) as determined by number of participants with dose limiting toxicities (DLT)

  Through the study completion, an average of 12 weeks

• Major Pathologic Response

  Time of surgery

• Objective response rate (ORR)

  Through the study completion, an average of 12 weeks

• Progression free survival(PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (2)

Camrelizumab+Dalpiciclib(100mg) 3 patients

EXPERIMENTAL

Camrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles. For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.

Drug: Camrelizumab; Drug: Dalpiciclib 100mg

Camrelizumab+Dalpiciclib(150mg) 3 patients

EXPERIMENTAL

Camrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles. For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.

Drug: Camrelizumab; Drug: Dalpiciclib 150mg

Interventions

Camrelizumab DRUG

Camrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery

Camrelizumab+Dalpiciclib(100mg) 3 patients; Camrelizumab+Dalpiciclib(150mg) 3 patients

Dalpiciclib 100mg DRUG

Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

Camrelizumab+Dalpiciclib(100mg) 3 patients

Dalpiciclib 150mg DRUG

Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

Camrelizumab+Dalpiciclib(150mg) 3 patients

Eligibility Criteria

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

You may qualify if:

• Age 18 years or above.
• Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following conditions:
• were newly diagnosed and without distant metastasis;
• were deemed surgically resectable evaluated by a head and neck surgeon;
• were willing to undergo surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Adequate organ and bone marrow function: absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L;ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN;albumin≥ 2.8 g/dL；creatinine clearance ≥ 60 ml/min；INR≤ 1.5；APTT≤ 1.5×ULN
• Written informed consent.

You may not qualify if:

• History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
• Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
• Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
• With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc.
• With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
• With hyperthyroidism, or organic thyroid disease.
• With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
• With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
• History of a clear neurological or psychiatric disorder.
• History of drug abuse or alcohol abuse.
• Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
• Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (9)

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MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; dalpiciclib

Condition Hierarchy (Ancestors)

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

Study Officials

• Jin Zhou, MD.,PhD.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Zhou, MD.,PhD.

CONTACT

+8613880626596; zhoujin096@scu.edu.cn

Shangwei Sun

CONTACT

+8615291996883; sunshangwei@stu.scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: October 31, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CN (1)