Phase 2
N=432
Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Advanced Cutaneous Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02760498 ↗Enrolled (actual)
432
Serious AEs
45.0%
Results posted
Dec 2024
Primary outcome: Primary: Overall Response Rate (ORR) by Independent Central Review — 50.8; 44.9; 46.4; 61.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cemiplimab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) by Independent Central Review |
50.8; 44.9; 46.4; 61.9; 47.3 | — |
| SECONDARY ORR by Investigator Assessment |
50.8; 56.4; 55.4; 63.5; 52.7 | — |
| SECONDARY Duration of Response (DOR) by Independent Central Review |
NA; 41.9; 41.3; NA; 31.6 | — |
| SECONDARY DOR by Investigator Assessment |
NA; 41.9; 44.2; NA; NA | — |
| SECONDARY Progression-Free Survival (PFS) by Independent Central Review |
18.4; 18.5; 21.7; 32.2; 16.6 | — |
| SECONDARY PFS by Investigator Assessment |
16.6; 32.5; 15.2; 25.3; 16.5 | — |
| SECONDARY Overall Survival (OS) |
57.7; NA; 48.4; NA; NA | — |
| SECONDARY Complete Response (CR) Rate by Independent Central Review |
20.3; 12.8; 19.6; 22.2; 10.8 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score |
0.00; 5.56; 6.86; 0.96; 11.26; 5.30 | — |
| SECONDARY Number of Participants With Any Treatment Emergent Adverse Event (TEAE) |
59; 78; 55; 63; 9; 163 | — |
| SECONDARY Peak Concentration (Cmax) of Cemiplimab |
108; 84.1; 132; 174; 52.9; 96.3 | — |
| SECONDARY Trough Concentration (Ctrough) of Cemiplimab |
21.5; 26.3; 33.6; 32.1; 34.1; 23.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies |
1; 0; 0; 0; 0; 5 | — |
| SECONDARY ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays |
40.5; 49.2 | — |
| SECONDARY DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays |
31.6; NA | — |
| SECONDARY PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays |
10.7; 16.6 | — |
Summary
The goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) Cutaneous Squamous Cell Carcinoma (CSCC), or unresectable locally advanced CSCC.
Eligibility Criteria
Key Inclusion Criteria
- At least 1 measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
- Archived or newly obtained tumor material
- Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6)
- Surgical or radiological treatment of lesions contraindicated
Key Exclusion Criteria
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
- Prior treatment with an agent that blocks the PD-1/PD-L1pathway
- Prior treatment with a BRAF inhibitor
- Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
- Untreated brain metastasis(es) that may be considered active
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
- Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
- History of non-infectious pneumonitis within the last 5 years
- Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
- Known allergy to doxycycline or tetracycline
- Patients with a history of solid organ transplant
- Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02760498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.