Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

City Clinical Oncology Hospital No 1

Status and phase: Enrolling; Phase 2

Conditions: Neck Cancer

Treatments: Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05551767

HN01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Experimental arm

Experimental group

Description:

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.

Treatment:

Drug: Pembrolizumab