Eine Phase-II-Studie zu REGN2810, einem vollständig humanen monoklonalen Antikörper gegen Programmierten-Zelltod-1 bei Patienten mit fortgeschrittenem Basalzellkarzinom und progredienter Erkrankung unter Behandlung mit Hedgehog-Signalweg-Inhibitor oder Unverträglichkeit einer vorangegangenen Behandlung mit Hedgehog-Signalweg-Inhibitor

Drug: cemiplimab

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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