Trial Title:
Cemiplimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
NCT ID:
NCT05929664
Condition:
Locally Advanced Basal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Cemiplimab
Immunoglobulins
Immunoglobulin G
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
No Data Available
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
No Data Available
Intervention:
Intervention type:
Biological
Intervention name:
Cemiplimab
Description:
Given IV
Arm group label:
Treatment (cemiplimab)
Other name:
1801342-60-8
Other name:
Cemiplimab RWLC
Other name:
Cemiplimab-rwlc
Other name:
Immunoglobulin G4
Other name:
Anti-(Human Programmed Cell Death Protein 1) (Human Monoclonal REGN2810 Heavy Chain)
Other name:
Disulfide with Human Monoclonal REGN2810 kappa-chain
Other name:
Dimer
Other name:
Libtayo
Other name:
REGN2810
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (cemiplimab)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
computerized axial tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT SCAN
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (cemiplimab)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Treatment (cemiplimab)
Other name:
Quality of Life Assessment
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (cemiplimab)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging
Other name:
Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
nuclear magnetic resonance imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (cemiplimab)
Other name:
BIOPSY_TYPE
Other name:
Bx
Summary:
This phase II trial tests how well cemiplimab works in treating basal cell carcinoma of
the head and neck that has spread to nearby tissue or lymph nodes (locally advanced)
before surgery (neoadjuvant). Cemiplimab is a human recombinant monoclonal IgG4 antibody
that may allow the body's immune system to work against tumor cells. Giving cemiplimab
before surgery may make the tumor smaller and make it easier to remove.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess treatment response of locally advanced basal cell carcinoma (BCC) of the
head and neck (BCCHN) in the neoadjuvant, presurgical setting.
SECONDARY OBJECTIVES:
I. To assess functional organ preservation with neoadjuvant Cemiplimab therapy. II. To
assess pathologic response. III. To assess safety of neoadjuvant therapy. IV. To assess
changes in quality of life.
EXPLORATORY OBJECTIVE:
I. To assess treatment-related changes in the immune microenvironment related to
functional changes in immune cell composition.
OUTLINE:
Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 of each cycle.
Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression
or unacceptable toxicity. Patients with progressive disease may transition to standard of
care (SOC) hedgehog inhibitor (HHI) therapy. Patients undergo computed tomography (CT) or
magnetic resonance imaging (MRI) scans and collection of blood samples throughout the
trial. Patients also undergo biopsies during screening and on study.
Upon completion of study treatment, patients are followed up at 3 months and 6 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed, locally-advanced BCC of the head and neck requiring
greater than 30% auriculectomy, rhinectomy, upper or lower lip resection, orbital
exenteration (due to lid or orbital involvement), facial nerve sacrifice or Brigham
and Women's stage 2b or 3 disease of head and neck
* Tumor Specific Inclusion Criteria
- Tumor Site: Nose; Inclusion criteria: >= 30% involvement
- Tumor Site: Lips; Inclusion criteria: >= 30% involvement
- Tumor Site: Ear; Inclusion criteria: >= 30% involvement
- Tumor Site: Eyelid; Inclusion criteria: >= 50% involvement, American Joint
Committee on Cancer (AJCC) stage 3
- Tumor Site: Facial Nerve; Inclusion criteria: Clinical determination of need
for sacrifice by treating surgeon
- Tumor Site: Orbit; Inclusion criteria: Need for exenteration based on orbital
or lid involvement determined by the treating surgeon
- Tumor Site: BCC of the HN, not otherwise included in the above; Inclusion
criteria: BWH T2b: 2-3 high risk factors. T3: >= 4 high risk features or bone
invasion. High risk features include: >= 2 cm, poorly differentiated histology,
peak nasal inspiratory (PNI) >= 0.1 mm on biopsy or gross or radiographic
perineural invasion, invasion beyond subcutaneous fat
- Male or female, aged >= 18 years of age
- Performance status 0-1
- Must have a life expectancy of at least 6 months as judged by the treating physician
- Absolute neutrophil count 1500/ul or more
- Platelets 100,000/ul or more
- Hemoglobin 9 g/dl or more
- Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects
with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or
equal to 2.5 x the upper limit of normal
- Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the
Cockcroft-Gault formula or measured creatinine clearance using 24 hours urine
collection
- Women of reproductive potential should have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin
[HCG]), which must also be confirmed as negative within 28 days of the start of
study drugs
- Women of reproductive potential must use highly effective contraception methods to
avoid pregnancy for 90 days after the last dose of study drugs. "Women of
reproductive potential" is defined as any female who has experienced menarche and
who has not undergone surgical sterilization (hysterectomy or bilateral
oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12
months of amenorrhea in a woman over 45 in the absence of other biological or
physiological causes. In addition, women under the age of 55 must have a documented
serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
- Men of reproductive potential who are sexually active with women of reproductive
potential must use any contraceptive method with a failure rate of less than 1% per
year. Men who are receiving the study medications will be instructed to adhere to
contraception for 90 days after the last dose of study drugs. Men who are
azoospermic do not require contraception
- Informed Consent: All subjects must be able to comprehend and sign a written
informed consent document
Exclusion Criteria:
- Prior radiation therapy within the past 6 months for this target cancer documented
by surgeon at Visit 1, Day 0 initial assessment. (Prior surgical resection to
area/tumor is acceptable)
- Any history of allergy to the study drug components
- Any concurrent malignancies: exceptions include- basal cell carcinoma of the skin at
another site, chronic lymphocytic leukemia, melanoma in situ, squamous cell
carcinoma of the skin of a secondary location, superficial bladder cancer or in situ
cervical cancer that has undergone potentially curative therapy. Patients with a
history of other prior malignancy must have been treated with curative intent and
must have remained disease-free for 2 years post-diagnosis
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events (CTCAE) version (v) 5.0 Grade >= 2 from previous anticancer
therapy with the exception of alopecia, vitiligo, and the laboratory values defined
in the inclusion criteria. Patients with Grade >= 2 neuropathy will be evaluated on
a case-by-case basis after consultation with the Study Physician. Patients with
irreversible toxicity not reasonably expected to be exacerbated by treatment with
anti-PD1 therapy may be included only after consultation with the Study Physician.
- Any Subjects with a condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive
medications within 28 days of study drug administration., or a prior history of
allogenic organ transplantation
- Any diagnosis of a significant connective tissue disorder as determined by the
treating surgeon or medical team
- Patients must not be receiving any other investigational agents
- Receipt of a live attenuated vaccine within 30 days prior to the first dose of drug
on trial
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
situations that would limit compliance with study requirement, substantially
increase risk of incurring AEs or compromise the ability of the patient to give
written informed consent
- Patients must not be pregnant or breastfeeding
- Active infection including tuberculosis (TB) (clinical evaluation that includes
clinical history, physical examination and radiographic findings, and TB testing in
line with local practice), hepatitis B (known positive hepatitis B virus [HBV]
surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus
[positive HIV 1/2 antibodies]). Patients with a past or resolved HBV infection
(defined as the presence of hepatitis B core antibody [anti-HBc]and absence of
HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible
only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
- Any patient with prior immunotherapy or hedge hog inhibitor (HHI) for malignancy
treatment
- Any untreated metastasis(es) to the brain that may be considered active
- History of pneumonitis with the past 5 years
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joseph Curry, MD
Phone:
215-955-6760
Email:
Joseph.Curry@jefferson.edu
Start date:
July 5, 2023
Completion date:
July 5, 2027
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05929664
