HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer

NCT04188951 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HFHS-1801
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.

Conditions

Head and Neck Neoplasms

Keywords

Recurrent Head and Neck Cancer; Recurrent Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).

  Primary objective

  1 year

Secondary Outcomes (3)

• Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.

  1 year

• Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.

  through study completion, an average of 1 year

• Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.

  through study completion, an average of 1 year

Study Arms (1)

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

OTHER

Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Interventions

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] DRUG

Patients will receive 17 cycles of pembrolizumab via IV infusion of 200 mg over a period of 30 minutes, every 3 weeks starting no later than 90 days from the date of salvage head and neck therapy.

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study.
• Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors.
• All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy.
• All patients must have undergone salvage surgery in an attempt to excise all recurrent disease.
• Salvage radiation therapy must not be an option available to the patient.
• Patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism.

You may not qualify if:

• Patients with macroscopic residual disease
• Patient is eligible for radiation therapy.
• Performance status more than 2.
• Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline.
• Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers
• Patients previously treated with immunotherapy \<12months prior

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Haythem Ali, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Pilot study

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: December 6, 2019
• Study Start: October 4, 2019
• Primary Completion: June 15, 2023
• Study Completion: May 8, 2024
• Last Updated: December 4, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after the study has completed enrollment and patient treatment. The data will be available indefinitely unless specified.
• Access Criteria: Access will be limited to collaborators within and beyond Henry Ford Health System.

Locations

US (1)