Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx

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.

Study Overview

• Status: Recruiting
• Conditions: Neck Cancer
• Intervention / Treatment: Drug: Pembrolizumab

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ilya А Pokataev; Phone Number: +79262858986; Email: pokia@mail.ru
• Study Contact Backup: Name: Olesya Stativko; Phone Number: +79061522724; Email: olesya_stativko@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 111123
    • Recruiting
    • Moscow Clinical Scientific Center named after Loginov
    • Contact: Ludmila G Zhukova
  • Moscow, Russian Federation, 129090
    • Recruiting
    • City clinical oncology hospital 1
    • Contact: Ilya A Pokataev; Phone Number: +79262858986; Email: pokia@mail.ru
  • Moscow, Russian Federation, 143423
    • Recruiting
    • Moscow City Oncology Hospital № 62
    • Contact: Daniil L Stroyakovsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental arm; 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.

Drug: 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); Other Names: cisplatin and 5-FU

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: City Clinical Oncology Hospital No 1
• Collaborators: Moscow Clinical Scientific Center; Moscow City Oncology Hospital No. 62
• Investigators: Principal Investigator: Vsevolod N Galkin, Professor, City Clinical Oncology Hospital No 1

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cisplatin; Pembrolizumab
• Other Study ID Numbers: HN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No