Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

NCT05551767 | Unknown Phase 2

• 1 other identifier: HN01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• overall survival

  through study completion, an average of 3 years

• objective response rate

  through study completion, an average of 3 years

• Organ-preserving treatment rate

  through study completion, an average of 3 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

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

Interventions

Pembrolizumab DRUG

3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg)

Also known as: cisplatin and 5-FU

Experimental arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• City Clinical Oncology Hospital No 1: lead
• Moscow City Oncology Hospital No. 62: collaborator
• Moscow Clinical Scientific Center: collaborator

Study Sites (3)

Moscow Clinical Scientific Center named after Loginov

Moscow, 111123, Russia

RECRUITING

City clinical oncology hospital 1

Moscow, 129090, Russia

RECRUITING

Moscow City Oncology Hospital No 62

Moscow, 143423, Russia

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumab; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vsevolod N Galkin, Professor

  City Clinical Oncology Hospital No 1

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilya А Pokataev

CONTACT

+79262858986; pokia@mail.ru

Olesya Stativko

CONTACT

+79061522724; olesya_stativko@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 23, 2022
• Study Start: August 30, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)