Locally Advanced Basal Cell CarcinomaPhase 2NCT05929664
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
A Phase 2 study testing Cemiplimab, Computed Tomography and Biospecimen Collection in people with Locally Advanced Basal Cell Carcinoma and Basal Cell Carcinoma, run by Thomas Jefferson University at 3 sites in United States.
Trial summary
A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Basal Cell Carcinoma, Basal Cell Carcinoma
- What is being tested?
- Cemiplimab, Computed Tomography and Biospecimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Jul 2023to 5 Jul 2031
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Pathologically confirmed, locally-advanced BCC of the head and neck of any stage which is not resectable without major morbidity or unresectable, defined as requiring greater than 30% auriculectomy, rhinectomy, upper or lower lip resection, orbital exenteration (due to lid or orbital involvement), facial nerve sacrifice, or any Brigham and Women's stage 2b or 3 disease of head and neck (see Table 5).
- 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.
- Adequate organ function:
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- Absolute neutrophil count 1500/μl or more;
- Platelets 100,000/μl 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);
- AST and ALT less than or equal to 2.5 x the upper limit of normal,
- 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 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 120 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 120 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 NCI CTCAE 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.
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- 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 (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive 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 HCVRNA.
- Any patient with prior immunotherapy or HHI for malignancy treatment.
- Any untreated metastasis(es) to the brain that may be considered active.
- History of pneumonitis with the past 5 years.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami Health System
Miami, Florida, 33136
Vanderbilt University
Nashville, Tennessee, 37232
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Neoadjuvant REGN2810 (Cemiplimab) or REGN2810 (Cemiplimab) Plus REGN3767 (Fianlimab) in Cutaneous Basal Cell Carcinoma of the Head and Neck
A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.
Read the detailed description
The proposed study is a phase II trial of neoadjuvant Cemiplimab (cohort 1) or Cemiplimab plus Fianlimab (cohort 2) that will target patients with advanced BCCHN who have not been previously treated with anti-PD1 checkpoint therapy for this primary lesion. Patients will be assessed by the enrolling surgeon for response to therapy every 3 weeks (before initiating the next cycle) by clinical assessment, and by imaging assessment (every 6 weeks). Patients will undergo a minimum of 2 cycles of therapy over a 6-week window prior to surgery. Patients who demonstrate clinical or RECISTv1.1 response or stable disease with regression or up to 5% growth, will go on to the next cycle of treatment. Patients who demonstrate clinical or RECISTv1.1 radiographic progression or stable disease with >5%-20% growth will proceed directly to surgery or to other SOC therapy (after biopsies) (Fig 1). Patients who demonstrate a complete clinical response prior to at any assessment prior to completion of 6 cycles will proceed to appropriate surgery or biopsy of tumor site to ensure complete pathologic response at the time of CR.
PRIMARY OBJECTIVE:
- Our primary objective is to assess treatment response of locally advanced BCC of the head and neck (BCCHN) in the neoadjuvant, presurgical setting.
SECONDARY OBJECTIVES:
- To assess functional organ preservation with neoadjuvant Cemiplimab or Cemiplimab plus Fianlimab therapy.
II. To assess pathologic response. III. To assess safety of neoadjuvant therapy. IV. To assess changes in quality of life.
EXPLORATORY OBJECTIVE:
- To assess treatment-related changes in the immune microenvironment related to functional changes in immune cell composition.
- Being tested
- Cemiplimab, Computed Tomography, Biospecimen Collection, Quality-of-Life Assessment, Magnetic Resonance Imaging
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabBiological
Also called 1801342-60-8, Cemiplimab RWLC, Cemiplimab-rwlc, Immunoglobulin G4
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT scan
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
FianlimabBiological
Also called REGN3767, Anti-LAG-3 MoAb
Fianlimab (REGN3767) administered intravenously in combination with Cemiplimab.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Cemiplimab | Experimental | Patients will undergo 2 infusions of Cemiplimab (Cemi), 350 mg every 3 weeks. Patients undergo CT or MRI scans and collection of blood samples throughout the trial. Patients also undergo biopsies during screening and on study.
The recommended dose of Cemiplimab is 350 mg as an intravenous infusion over 30 minutes every 3 weeks (constituting one cycle). Dosing will occur in this manner for a single dose of 350mg Cemiplimab every 3 weeks constituting 1 cycle of therapy. Patients will undergo at least 2 cycles of Cemiplimab and at most, 4 additional cycles dependent upon treatment response. Receives: Biological: Cemiplimab; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment; Procedure: Magnetic Resonance Imaging; Procedure: Biopsy |
| Cohort 2: Fianlimab + Cemiplimab | Experimental | Patients will undergo infusions of Cemiplimab (C) and Fianlimab (F), 350 mg Cemiplimab + 1600 mg Fianlimab every 3 weeks. Fianlimab in combination with cemiplimab can be administered to patients in a sequential order through co-administration, or concurrently via a fixed-dose combination (FDC). When the FDC is used, the drug product containing co-formulated drugs in a vial is injected into the IV bag and delivered intravenously to the patient.
FDC of fianlimab 1600 mg + cemiplimab 350 mg will be administered as a single infusion over 30 to 40 minutes every 3 weeks (constituting one cycle). Patients will undergo at least 2 cycles of the FDC and at most, 4 additional cycles dependent upon treatment response. Receives: Biological: Cemiplimab; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment; Procedure: Magnetic Resonance Imaging; Procedure: Biopsy; Biological: Fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Defined by responders at surgery using clinical assessment and RECIST v1.1. Results will be summarized with frequency counts, percentages, and exact Clopper-Pearson 95% CIs. Tumor response will follow RECIST v1.1: up to five target lesions (max two per organ) measured by longest diameter (non-nodal) or short axis (nodal). Complete Response is disappearance of all target lesions and lymph nodes <10 mm. Partial Response is ≥30% decrease from baseline. Progressive Disease is ≥20% increase (and ≥5 mm growth) from the smallest on-study sum or the appearance of new lesions. Stable Disease applies when changes do not meet PR or PD. Reasons for unevaluable cases will be documented.
Measured: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Disease control rate (DCR)
Defined responders plus stable disease using clinical assessment and RECIST v1.1. Results will be summarized by frequency counts, percentages, and exact Clopper-Pearson 95% CIs. Tumor response will follow RECIST v1.1: up to five target lesions (no more than two per organ) measured by longest diameter (non-nodal) or short axis (nodal). Complete Response is disappearance of all target lesions and lymph nodes <10 mm. Partial Response is ≥30% decrease from baseline. Progressive Disease is ≥20% increase (and ≥5 mm growth) from the smallest on-study sum or new lesions. Stable Disease applies when changes do not meet PR or PD. Reasons for unevaluable cases will be documented.
Measured: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Secondary outcomes (10)
Surgical/Clinical Benefit Rate (SBR)
Percentage of patients with an organ at risk demonstrating tumor response allowing functional organ preservation surgery.
Measured: At surgery (Day 129 +/- 3 days)
Pathologic complete response (pCR)
Pathologic complete response (pCR)
Measured: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Major pathologic response (mPR)
Major pathologic response (mPR)
Measured: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Number of adverse events
Safety and tolerability assessed using CTCAE v5.0.
Measured: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (FHNSI)
Assessed by the Functional Assessment of Cancer Therapy - Head and Neck Symptom Index (FHNSI), FACE-Questionnaire (Q), Visual Function Questionnaire (VFQ)-25 validated questionnaires. Summarized with descriptive statistics and plotted graphically (i.e., with box plots). Those data will be modeled using generalized linear modeling to account for the correlation of the longitudinal observations from the same patient.
Measured: At baseline (Day 1) to 6 months post-surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (FACE-Q)
Assessed by the Functional Assessment of Cancer Therapy Questionnaire (FACE-Q), validated questionnaires. Score range: 0-100, generally higher scores reflect a better outcome. Summarized with descriptive statistics and plotted graphically (i.e., with box plots). Those data will be modeled using generalized linear modeling to account for the correlation of the longitudinal observations from the same patient.
Measured: At baseline (Day 1)
Changes in quality of life and functional organ preservation (VFQ-25)
Assessed by the Visual Function Questionnaire (VFQ-25) validated questionnaires. Score range: 0-100, higher scores reflect a better outcome. Summarized with descriptive statistics and plotted graphically (i.e., with box plots). Those data will be modeled using generalized linear modeling to account for the correlation of the longitudinal observations from the same patient.
Measured: At baseline (Day 1)
Changes in quality of life and functional organ preservation (FHNSI)
Assessed by the Functional Assessment of Cancer Therapy - Head and Neck Symptom Index (FHNSI) validated questionnaires. Score range: 0-40, higher scores reflect a better outcome. Summarized with descriptive statistics and plotted graphically (i.e., with box plots). Those data will be modeled using generalized linear modeling to account for the correlation of the longitudinal observations from the same patient.
Measured: 6 months post-surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (FACE-Q)
Assessed by the Functional Assessment of Cancer Therapy Questionnaire (FACE-Q), validated questionnaires. Score range: 0-100, generally higher scores reflect a better outcome. Summarized with descriptive statistics and plotted graphically (i.e., with box plots). Those data will be modeled using generalized linear modeling to account for the correlation of the longitudinal observations from the same patient.
Measured: 6 months post-surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (VFQ-25)
Assessed by the Visual Function Questionnaire (VFQ-25) validated questionnaires. Score range: 0-100, higher scores reflect a better outcome. Summarized with descriptive statistics and plotted graphically (i.e., with box plots). Those data will be modeled using generalized linear modeling to account for the correlation of the longitudinal observations from the same patient.
Measured: 6 months post-surgery (up to Day 309 +/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start5 Jul 2023
- Primary completion5 Jul 2031 (estimated)
- Study completion5 Jul 2031 (estimated)
Why it stopped: Investigational product is not currently available to the study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Joseph Curry, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929664
- Sponsor's protocol ID
- iRISID-2022-0944
- Other IDs
- JT 24369
- Status last verified
- May 2026
- First submitted
- 7 Feb 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant REGN2810 (Cemiplimab) or REGN2810 (Cemiplimab) Plus REGN3767 (Fianlimab) in Cutaneous Basal Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT05929664
- Acronym / sponsor ID
- iRISID-2022-0944
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Investigational product is not currently available to the study site.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 5 Jul 2031 (estimated)
- Study completion
- 5 Jul 2031 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.
Detailed description
The proposed study is a phase II trial of neoadjuvant Cemiplimab (cohort 1) or Cemiplimab plus Fianlimab (cohort 2) that will target patients with advanced BCCHN who have not been previously treated with anti-PD1 checkpoint therapy for this primary lesion. Patients will be assessed by the enrolling surgeon for response to therapy every 3 weeks (before initiating the next cycle) by clinical assessment, and by imaging assessment (every 6 weeks). Patients will undergo a minimum of 2 cycles of therapy over a 6-week window prior to surgery. Patients who demonstrate clinical or RECISTv1.1 response or stable disease with regression or up to 5% growth, will go on to the next cycle of treatment. Patients who demonstrate clinical or RECISTv1.1 radiographic progression or stable disease with >5%-20% growth will proceed directly to surgery or to other SOC therapy (after biopsies) (Fig 1). Patients who demonstrate a complete clinical response prior to at any assessment prior to completion of 6 cycles will proceed to appropriate surgery or biopsy of tumor site to ensure complete pathologic response at the time of CR.
PRIMARY OBJECTIVE:
- Our primary objective is to assess treatment response of locally advanced BCC of the head and neck (BCCHN) in the neoadjuvant, presurgical setting.
SECONDARY OBJECTIVES:
- To assess functional organ preservation with neoadjuvant Cemiplimab or Cemiplimab plus Fianlimab therapy.
II. To assess pathologic response. III. To assess safety of neoadjuvant therapy. IV. To assess changes in quality of life.
EXPLORATORY OBJECTIVE:
- To assess treatment-related changes in the immune microenvironment related to functional changes in immune cell composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Cemiplimab | Experimental | Biological: Cemiplimab, Procedure: Computed Tomography, Procedure: Biospecimen Collection, Other: Quality-of-Life Assessment, Procedure: Magnetic Resonance Imaging, Procedure: BiopsyPatients will undergo 2 infusions of Cemiplimab (Cemi), 350 mg every 3 weeks. Patients undergo CT or MRI scans and collection of blood samples throughout the trial. Patients also undergo biopsies during screening and on study. The recommended dose of Cemiplimab is 350 mg as an intravenous infusion over 30 minutes every 3 weeks (constituting one cycle). Dosing will occur in this manner for a single dose of 350mg Cemiplimab every 3 weeks constituting 1 cycle of therapy. Patients will undergo at least 2 cycles of Cemiplimab and at most, 4 additional cycles dependent upon treatment response. |
| Cohort 2: Fianlimab + Cemiplimab | Experimental | Biological: Cemiplimab, Procedure: Computed Tomography, Procedure: Biospecimen Collection, Other: Quality-of-Life Assessment, Procedure: Magnetic Resonance Imaging, Procedure: Biopsy, Biological: FianlimabPatients will undergo infusions of Cemiplimab (C) and Fianlimab (F), 350 mg Cemiplimab + 1600 mg Fianlimab every 3 weeks. Fianlimab in combination with cemiplimab can be administered to patients in a sequential order through co-administration, or concurrently via a fixed-dose combination (FDC). When the FDC is used, the drug product containing co-formulated drugs in a vial is injected into the IV bag and delivered intravenously to the patient. FDC of fianlimab 1600 mg + cemiplimab 350 mg will be administered as a single infusion over 30 to 40 minutes every 3 weeks (constituting one cycle). Patients will undergo at least 2 cycles of the FDC and at most, 4 additional cycles dependent upon treatment response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- -Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Pathologically confirmed, locally-advanced BCC of the head and neck of any stage which is not resectable without major morbidity or unresectable, defined as requiring greater than 30% auriculectomy, rhinectomy, upper or lower lip resection, orbital exenteration (due to lid or orbital involvement), facial nerve sacrifice, or any Brigham and Women's stage 2b or 3 disease of head and neck (see Table 5).
- 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.
Key exclusion criteria (15 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 NCI CTCAE 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: 1801342-60-8, Cemiplimab RWLC, Cemiplimab-rwlc, Immunoglobulin G4Given IV | Biological | Cohort 1: Cemiplimab, Cohort 2: Fianlimab + Cemiplimab |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT scan | Procedure or surgery | Cohort 1: Cemiplimab, Cohort 2: Fianlimab + Cemiplimab |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Cohort 1: Cemiplimab, Cohort 2: Fianlimab + Cemiplimab |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Cohort 1: Cemiplimab, Cohort 2: Fianlimab + Cemiplimab |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Cohort 1: Cemiplimab, Cohort 2: Fianlimab + Cemiplimab |
| BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Cohort 1: Cemiplimab, Cohort 2: Fianlimab + Cemiplimab |
| FianlimabAlso: REGN3767, Anti-LAG-3 MoAbFianlimab (REGN3767) administered intravenously in combination with Cemiplimab. | Biological | Cohort 2: Fianlimab + Cemiplimab |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Defined by responders at surgery using clinical assessment and RECIST v1.1. Results will be summarized with frequency counts, percentages, and exact Clopper-Pearson 95% CIs. Tumor response will follow RECIST v1.1: up to five target lesions (max two per organ) measured by longest diameter (non-nodal) or short axis (nodal). Complete Response is disappearance of all target lesions and lymph nodes <10 mm. Partial Response is ≥30% decrease from baseline. Progressive Disease is ≥20% increase (and ≥5 mm growth) from the smallest on-study sum or the appearance of new lesions. Stable Disease applies when changes do not meet PR or PD. Reasons for unevaluable cases will be documented.
Disease control rate (DCR)
Time frame: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Defined responders plus stable disease using clinical assessment and RECIST v1.1. Results will be summarized by frequency counts, percentages, and exact Clopper-Pearson 95% CIs. Tumor response will follow RECIST v1.1: up to five target lesions (no more than two per organ) measured by longest diameter (non-nodal) or short axis (nodal). Complete Response is disappearance of all target lesions and lymph nodes <10 mm. Partial Response is ≥30% decrease from baseline. Progressive Disease is ≥20% increase (and ≥5 mm growth) from the smallest on-study sum or new lesions. Stable Disease applies when changes do not meet PR or PD. Reasons for unevaluable cases will be documented.
10 secondary outcomes
Surgical/Clinical Benefit Rate (SBR)
Time frame: At surgery (Day 129 +/- 3 days)
Pathologic complete response (pCR)
Time frame: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Major pathologic response (mPR)
Time frame: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Number of adverse events
Time frame: Up to 6 months post surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (FHNSI)
Time frame: At baseline (Day 1) to 6 months post-surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (FACE-Q)
Time frame: At baseline (Day 1)
Changes in quality of life and functional organ preservation (VFQ-25)
Time frame: At baseline (Day 1)
Changes in quality of life and functional organ preservation (FHNSI)
Time frame: 6 months post-surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (FACE-Q)
Time frame: 6 months post-surgery (up to Day 309 +/- 3 days)
Changes in quality of life and functional organ preservation (VFQ-25)
Time frame: 6 months post-surgery (up to Day 309 +/- 3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Locally Advanced Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Curry, MD principal investigator
Thomas Jefferson University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab, Computed Tomography and Biospecimen Collection in people with Locally Advanced Basal Cell Carcinoma and Basal Cell Carcinoma, run by Thomas Jefferson University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 6 months post surgery (up to Day 309 +/- 3 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.