Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

Phase 2

Recruiting

• Conditions: Neck Cancer
• Interventions: Drug: Pembrolizumab

• Registration Number: NCT05551767
• Lead Sponsor: City Clinical Oncology Hospital No 1

Brief Summary

patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.

Detailed Description

patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.

Study Timeline

• Study Start: 2022-08-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification;
• Tumor is morphlogically confirmed;
• CPS>1 (22C3 clone);
• ECOG 0-2;
• Age above 18 years;
• Signed Informed consent form.

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Exclusion Criteria

• Cancer of nasopharynx;
• Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer;
• Stages I or II;
• ECOG>=3.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Pembrolizumab	3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.

Primary Outcome Measures

Name	Time	Method
complete response rate	through study completion, an average of 3 years	rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy
progression-free survival	through study completion, an average of 3 years	Time from start of treatment to radiological disease progression

Secondary Outcome Measures

Name	Time	Method
overall survival	through study completion, an average of 3 years	Time from start of treatment to death from any case
Organ-preserving treatment rate	through study completion, an average of 3 years	rate of patients with organ sparing treatment
objective response rate	through study completion, an average of 3 years	response rate by RESCIST 1.1

Trial Locations

Locations (3)

City clinical oncology hospital 1; 🇷🇺 Moscow, Russian Federation

Moscow Clinical Scientific Center named after Loginov; 🇷🇺 Moscow, Russian Federation

Moscow City Oncology Hospital No 62; 🇷🇺 Moscow, Russian Federation