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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
