Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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

Male or female, aged >= 18 years of age

Performance status 0-1

Performance status 0-1

Must have a life expectancy of at least 6 months as judged by the treating physician

Must have a life expectancy of at least 6 months as judged by the treating physician

Absolute neutrophil count 1500/ul or more

Absolute neutrophil count 1500/ul or more

Platelets 100,000/ul or more

Platelets 100,000/ul or more

Hemoglobin 9 g/dl 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)

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

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

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 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

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

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

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)

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 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 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 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 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

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

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

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

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

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)

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 patient with prior immunotherapy or hedge hog inhibitor (HHI) for malignancy treatment

Any untreated metastasis(es) to the brain that may be considered active

Any untreated metastasis(es) to the brain that may be considered active

History of pneumonitis with the past 5 years

History of pneumonitis with the past 5 years