Education and Training
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: cemiplimab
Eligibility
Key Inclusion Criteria:
- Confirmed diagnosis of invasive BCC
- Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
therapy
- At least 1 measurable lesion
- ≥18 years of age
- Hepatic function, renal function, bone marrow function in defined lab-value-ranges
- Anticipated life expectancy >12 weeks
- Consent to provide archived tumor biopsy material (all patients)
- Group 2: consent to undergo research biopsies
- Group 2: must not be a candidate for radiation therapy or surgery
- Comply with study procedures and site visits
- Sign Subject Information Sheet and Informed Consent Form
Key Exclusion Criteria:
- Ongoing or recent significant autoimmune disease
- Prior treatment with specific pathway-blockers (PD-1/PD-L1)
- Prior treatment with immune-modulating agents within 28 days before cemiplimab
- Untreated brain metastasis that may be considered active
- Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
treatment with cemiplimab
- Active infections requiring therapy, including HIV, hepatitis
- Pneumonitis within the last 5 years
- Cancer treatment other than radiation therapy, including investigational or standard
of care, within 30 days prior to treatment with cemiplimab
- Documented allergic reactions or similar to antibody treatments
- Concurrent malignancies other than BCC, other than those with negligible risk of
metastases or death
- Any acute or chronic psychiatric problems
- Having received a solid organ transplantation
- Inability to undergo contrast radiological assessments
- Breastfeeding, pregnant, women of childbearing potential not using contraception
Note: Other protocol-defined inclusion/exclusion criteria apply
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alexander Ayon Valencia
650-498-5185
Not Recruiting