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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03889912




Registration number
NCT03889912
Ethics application status
Date submitted
6/03/2019
Date registered
26/03/2019

Titles & IDs
Public title
Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
Scientific 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)
Secondary ID [1] 0 0
2024-511440-76-00
Secondary ID [2] 0 0
R2810-ONC-1787
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma 0 0
Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cemiplimab

Experimental: Cemiplimab - Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B.

Note: Cohort E through G will not be opened for participation.


Treatment: Drugs: Cemiplimab
Each patient will receive intralesional injections of cemiplimab every week (QW), or at less frequent dosing into the lesion at the assigned dose level for 3-12 weeks prior to scheduled surgery
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From the first dose through day 28
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From the first dose to 90 days after the last dose
Primary outcome [3] 0 0
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
Timepoint [3] 0 0
From the first dose up to 90 days after the last dose
Primary outcome [4] 0 0
The incidence and severity of injection site reactions (ISRs)
Timepoint [4] 0 0
From the first dose to 90 days after the last dose
Secondary outcome [1] 0 0
Objective response rate (ORR) of index lesion
Timepoint [1] 0 0
At baseline and at Week 13
Secondary outcome [2] 0 0
Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Timepoint [2] 0 0
At time of surgery
Secondary outcome [3] 0 0
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
Timepoint [3] 0 0
At time of surgery
Secondary outcome [4] 0 0
Cemiplimab concentration in serum over time
Timepoint [4] 0 0
From the first dose up to 90 days after the last dose
Secondary outcome [5] 0 0
Incidence of anti-drug antibody (ADA) titers for cemiplimab
Timepoint [5] 0 0
Up to 90 days after last dose
Secondary outcome [6] 0 0
Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
Timepoint [6] 0 0
Up to 90 days after last dose

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/10/2027
Actual
Sample size
Target
113
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment hospital [3] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03889912