Clinical trial NCT03889912: Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
Official title: A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cutaneous Squamous Cell Carcinoma
Basal Cell Carcinoma
Keywords: CSCC
BCC
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohorts A, B, D and H will enroll sequentially (not randomized). Cohort C and I for BCC will enroll in parallel with, and independently of, Cohorts A, B, D and H for CSCC patients
Primary purpose: TREATMENT

Brief summary: This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).

The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).

The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.

The study is also looking at several other research questions, including:

* What side effects may happen from taking the study drug
* To see effect of cemiplimab on the tumor
* How much study drug is in the blood at different times


Eligibility criteria: Key Inclusion Criteria

1. Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
2. Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key Exclusion Criteria

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
2. Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
3. Prior treatment with other systemic immune modulating agent as defined in the protocol
4. M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
5. Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
6. Patients with a history of solid organ transplant
7. Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Primary outcomes:
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
timeFrame: From the first dose through day 28
measure: Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
timeFrame: From the first dose to 90 days after the last dose
measure: Incidence and severity of TEAEs graded according to the NCI CTCAE v5
timeFrame: From the first dose up to 90 days after the last dose
measure: The incidence and severity of injection site reactions (ISRs)
timeFrame: From the first dose to 90 days after the last dose
Secondary outcomes:
measure: Objective response rate (ORR) of index lesion
timeFrame: At baseline and at Week 13
measure: Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
timeFrame: At time of surgery
measure: Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
timeFrame: At time of surgery
measure: Cemiplimab concentration in serum over time
timeFrame: From the first dose up to 90 days after the last dose
measure: Incidence of anti-drug antibody (ADA) titers for cemiplimab
timeFrame: Up to 90 days after last dose
measure: Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
timeFrame: Up to 90 days after last dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Redwood City
country: United States
facility: Stanford University School of Medicine
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Delray Beach
country: United States
facility: Dermatology Associates of the Palm Beaches
state: Florida
city: Tampa
country: United States
facility: MCC - Magnolia Drive, SRB-3
state: Florida
city: Atlanta
country: United States
facility: MetroDerm
state: Georgia
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Beverly
country: United States
facility: Northeast Dermatology Associates
state: Massachusetts
city: New York
country: United States
facility: Dermatology Surgery Associates
state: New York
city: Victor
country: United States
facility: Rochester Dermatologic Surgery, P.C.
state: New York
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek
state: Noord-Holland
city: Groningen
country: Netherlands
facility: University of Groningen, University Medical Centre Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: