Loading clinical trials...

NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT04588038•Hyunseok Kang, MD

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx with recurrent disease which is amenable for curative intent surgical resection
•Age \>= 18 years.
•Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
•Absolute neutrophil count \>= 1,500/microliter (mcL)
•Platelets \>= 100,000/mcL
•Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits
•Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =\< 3 X institutional upper limit of normal
•Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT) =\< 3 X institutional upper limit of normal
•Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN for subjects with documented liver involvement or bone metastases)
•Creatinine =\< 1.5 x within institutional upper limit of normal OR
+6 more criteria

Exclusion Criteria

•Had received immune check point inhibitor within 6 weeks prior to study entry OR chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry)
•Has history of autoimmune disease which requires active immune suppression (steroid replacement for iatrogenic deficiencies, prednisone 5 mg or less \[or equivalent dose\], or topical steroids are allowed)
•Is currently receiving any other investigational agents
•Has uncontrolled tumor-related pain
•Has uncontrolled intercurrent medical illness, including but not limited to congestive heart failure, recent acute cardiac event within 6 months, and recent major bleeding event within 6 months
•Pregnant women are excluded from this study because effects of NT-I7 on developing fetus is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with NT-I7, breastfeeding should be discontinued if the mother is treated with NT-I7
•Is not recovered from adverse events (AEs) (other than alopecia, vitiligo, neuropathy or endocrinopathy managed with replacement therapy) due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \> grade 1)
•Had major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study initiation
•Had concurrent or previous other malignancy within 5 years of study entry, except noninvasive or indolent malignancy
•Has spinal cord compression not definitively treated with surgery and/or radiation
+2 more criteria

Locations (1)

University of California San Francisco

San Francisco, California, United States

Key Dates

Start Date

March 12, 2021

Primary Completion Date

February 3, 2025

Completion Date

February 3, 2025

Last Updated

February 14, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaResectable Oropharyngeal Squamous Cell Carcinoma

Interventions

Efineptakin alfa

BIOLOGICAL

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

View study

RECRUITINGPHASE2

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

NCT06636734

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary+20 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases

Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer

Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers