Description:
The primary objective is to characterize the safety and tolerability of cemiplimab injected
intralesionally in patients with recurrent CSCC.
The secondary objectives of this study are:
- To describe the objective response rate (ORR) in CSCC index lesions following
intralesional injections of cemiplimab in patients with recurrent CSCC, according to
modified World Health Organization (WHO) criteria
- To describe the pathologic complete response (CR) rate in CSCC index lesions following
intralesional injections of cemiplimab in patients with recurrent CSCC
- To describe the major pathologic response rate in CSCC index lesions following
intralesional injections of cemiplimab in patients with recurrent CSCC
- To evaluate systemic exposure of cemiplimab following intralesional injections of
cemiplimab in patients with recurrent CSCC
- To assess the immunogenicity of cemiplimab in patients with recurrent CSCC
- To establish a recommended dose of intralesional cemiplimab for further study in
patients with recurrent CSCC
Title
- Brief Title: Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma
- Official Title: A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Recurrent Cutaneous Squamous Cell Carcinoma (CSCC)
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-1787
- NCT ID:
NCT03889912
Conditions
- Cutaneous Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Cemiplimab | REGN2810, Libtayo | Cemiplimab |
Purpose
The primary objective is to characterize the safety and tolerability of cemiplimab injected
intralesionally in patients with recurrent CSCC.
The secondary objectives of this study are:
- To describe the objective response rate (ORR) in CSCC index lesions following
intralesional injections of cemiplimab in patients with recurrent CSCC, according to
modified World Health Organization (WHO) criteria
- To describe the pathologic complete response (CR) rate in CSCC index lesions following
intralesional injections of cemiplimab in patients with recurrent CSCC
- To describe the major pathologic response rate in CSCC index lesions following
intralesional injections of cemiplimab in patients with recurrent CSCC
- To evaluate systemic exposure of cemiplimab following intralesional injections of
cemiplimab in patients with recurrent CSCC
- To assess the immunogenicity of cemiplimab in patients with recurrent CSCC
- To establish a recommended dose of intralesional cemiplimab for further study in
patients with recurrent CSCC
Trial Arms
Name | Type | Description | Interventions |
---|
Cemiplimab | Experimental | Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion | |
Eligibility Criteria
Key Inclusion Criteria
- History of recurrent resectable CSCC that satisfies conditions as defined in the
protocol
- Patient must have measurable disease in the index lesion, as defined by modified WHO
criteria. Measurable disease is defined as at least one lesion that is at least 1 cm
in both of the longest perpendicular diameters.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
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 (irAEs)
- Prior treatment with an agent that blocks the programmed cell death
1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
- Prior treatment with other systemic immune modulating agent as defined in the protocol
- M1 or N1, N2 (a, b, or c), or N3 CSCC. Patients with history of metastatic CSCC
(distant or nodal), are excluded unless the disease-free interval is at least 3 years
- Concurrent malignancies, other than those with negligible risk of metastasis or death.
Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL),
are excluded.
- Patients with a history of solid organ transplant
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 |
Time Frame: | From the first dose through day 28 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | Day 85 |
Safety Issue: | |
Description: | Determined by the investigator using the modified WHO criteria at the end of treatment for patients who complete planned 12-week treatment course |
Measure: | Pathologic complete response rate |
Time Frame: | At time of surgery |
Safety Issue: | |
Description: | |
Measure: | Major pathologic response rate |
Time Frame: | Up to 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Cemiplimab concentration in serum over time |
Time Frame: | From the first dose up to 90 days after the last dose |
Safety Issue: | |
Description: | |
Measure: | Incidence of anti-drug antibody (ADA) titers for cemiplimab |
Time Frame: | Up to 90 days after last dose |
Safety Issue: | |
Description: | |
Measure: | Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations |
Time Frame: | Up to 90 days after last dose |
Safety Issue: | |
Description: | The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
Last Updated
July 16, 2021