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

Sex

All

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

• DERIVEDStratigos AJ, Chen CI, Ivanescu C, Lewis KD, Peris K, Bechter O, Harnett J, Mastey V, Reaney M, Daskalopoulou C, LaFontaine PR, Konidaris G, Bury D, Yoo SY, Mohan K, Coates E, Bowler T, Fury MG, Sekulic A. Quality of life in cemiplimab-treated patients with locally advanced basal cell carcinoma in a Phase II clinical trial. Future Oncol. 2024;20(30):2249-2258. doi: 10.1080/14796694.2024.2358670. Epub 2024 Jul 29. PMID 39073799
• DERIVEDPeris K, Inocencio TJ, Stratigos AJ, Lewis KD, Eroglu Z, Chang ALS, Ivanescu C, Sekulic A, Fury MG, Chen CI, Quek RGW. Health-related quality of life in patients with metastatic basal cell carcinoma treated with cemiplimab: Analysis of a phase 2 trial. Cancer Med. 2024 Jul;13(14):e7360. doi: 10.1002/cam4.7360. PMID 39031963
• DERIVEDLewis KD, Peris K, Sekulic A, Stratigos AJ, Dunn L, Eroglu Z, Chang ALS, Migden MR, Yoo SY, Mohan K, Coates E, Okoye E, Bowler T, Baurain JF, Bechter O, Hauschild A, Butler MO, Hernandez-Aya L, Licitra L, Neves RI, Ruiz ES, Seebach F, Lowy I, Goncalves P, Fury MG. Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors. Ann Oncol. 2024 Feb;35(2):221-228. doi: 10.1016/j.annonc.2023.10.123. Epub 2023 Dec 9. PMID 38072158
• DERIVEDStratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Fernandez Orland A, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Yoo SY, Okoye E, Bassukas I, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Inocencio TJ, Chen CI, LaFontaine PR, Seebach F, Lowy I, Fury MG. Phase 2 open-label, multicenter, single-arm study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Extended follow-up. J Am Acad Dermatol. 2024 Feb;90(2):414-418. doi: 10.1016/j.jaad.2023.08.111. Epub 2023 Oct 14. No abstract available. PMID 37839734
• DERIVEDStratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. doi: 10.1016/S1470-2045(21)00126-1. Epub 2021 May 14.