Neoplasms

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Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Patients receive one dose of efineptakin alfa IM.

Efineptakin alfa

Angelica Valadez

Hyunseok Kang, MD

This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back (recurrent) who are undergoing surgery. NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells. The body produces T-cells which play an important role in body's immune response and its ability to recognize tumor cells. This immunotherapy drug may boost body's T-cells to help fight cancer and enhance body's response to cancer.

PRIMARY OBJECTIVE:

I. To evaluate safety and feasibility of a single intramuscular injection of efineptakin alfa (NT-I7) in patients with locally recurrent squamous cell carcinoma of head and neck (SCCHN).

SECONDARY OBJECTIVES:

I. To describe changes in absolute lymphocyte count (ALC) in peripheral blood after a single dose of NT-I7.

II. To describe changes in tumor infiltrating lymphocytes (TIL) in tumor microenvironment of surgical specimen after a single dose of NT-I7.

III. To evaluate changes in immune subsets in peripheral blood after a single dose of NT-I7 and after surgery.

EXPLORATORY OBJECTIVE:

I. To make assessment of exploratory biomarkers for pharmacodynamic activity of NT-I7 in peripheral blood, and/or tumor tissue.

OUTLINE:

Patients receive one dose of efineptakin alfa intramuscularly (IM).

After completion of study treatment, patients are followed up for 35 days after dose or 21 days after surgery.

NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

A Window of Opportunity Trial of NT-I7 in Patients With Locally Recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) Undergoing Salvage Surgery

Gene expression profiling by bulk ribonucleic acid (RNA)-sequencing or single cell RNA sequencing will be performed.

Gene expression profiling by T cell receptor (TCR) diversity via TCR sequencing (TCRseq) will be performed.

Circulating cytokine analysis will be performed on serum samples.

The proportion of patients experiencing grade 3 or 4 adverse events assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported with exact binomial 95% confidence intervals. Safety analyses will be performed for all patients who receive a dose of NT-I7

Feasibility will be evaluated as the successful completion of pre-operative NT-I7 and proceeding to pre-planned surgery without any extended treatment-related delay defined as \> 28 days from day 15. A probability-based decision rule for the study will be used to decide if the probability of successfully proceeding to surgery as planned is convincingly less than .75

Descriptive changes in ALC in peripheral blood both before and after a single dose of NT-I7 will be recorded.

Descriptive changes in tumor infiltrating lymphocytes in tumour microenvironment (TME) after a single dose of NT-I7 in pre-treatment biopsy and surgical specimen will be recorded.

Descriptive changes in immune phenotyping in peripheral blood after a single dose of NT-I7 and after surgery as measured by mass cytometry will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery	NCT04588038	Recurrent Head ... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Resectable Orop...	Efineptakin alf...	18 Years -	University of California, San Francisco
NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery	NCT04588038	Recurrent Head ... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Resectable Orop...	Efineptakin alf...	18 Years -	University of California, San Francisco
NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery	NCT04588038	Recurrent Head ... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Resectable Orop...	Efineptakin alf...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for resectable oropharyngeal squamous cell carcinoma