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.
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
- Patients must have at least grade 2 lymphopenia at baseline by Common Terminology
Criteria for Adverse Events (CTCAE) version (v)5.0 criteria (absolute lymphocyte count
< 800/uL)
- 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
- Creatinine clearance glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2,calculated
using the Cockcroft-Gault equation, unless data exists supporting safe use at lower
kidney function values, no lower than 30 mL/min/1.73 m^2
- Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated
- Individuals with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For individuals with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
- Individuals with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- The effects of NT-I7 on the developing human fetus are unknown. For this reason, women
of child-bearing potential and men must agree to use adequate contraception for the
duration of study participation and for 3 months after the study treatment. Should a
woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately
- Men treated or enrolled on this protocol must also agree to use adequate contraception
prior to the study, for the duration of study participation for 3 months after the
study treatment
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
- Has active autoimmune diseases including but not limited to systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis
associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's
syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis or
glomerulonephritis
- Has active and clinically relevant bacterial, fungal, viral, or Tuberculosis (TB)
infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV)
(testing not required) or have been hospitalized within 4 weeks prior to NT-I7
injection
