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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Basal Cell

Treatments: Drug: cemiplimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03132636

R2810-ONC-1620

2016-003122-16 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

138 participants in 2 patient groups

Group 1- metastatic BCC

Experimental group

Description:

Administration of cemiplimab in accordance with protocol dosing regimen

Treatment:

Drug: cemiplimab

Group 2 - unresectable locally advanced BCC

Experimental group

Description:

Administration of cemiplimab in accordance with protocol dosing regimen

Treatment:

Drug: cemiplimab