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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02760498




Registration number
NCT02760498
Ethics application status
Date submitted
8/04/2016
Date registered
3/05/2016
Date last updated
14/01/2019

Titles & IDs
Public title
Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Scientific title
A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Secondary ID [1] 0 0
R2810-ONC-1540
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cutaneous Squamous 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: Group 1 - Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 2 weeks.

Experimental: Group 2 - Patients with unresectable locally advanced CSCC. Cemiplimab administered intravenously every 2 weeks.

Experimental: Group 3 - Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 3 weeks.

Experimental: Group 4 - Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered intravenously every 4 weeks.


Treatment: Drugs: cemiplimab


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate - Groups 1, 3, and 4: RECIST version 1.1 will be used to determine ORR. Groups 2 and 4: Clinical response criteria will be used to determine ORR
Timepoint [1] 0 0
96 weeks
Secondary outcome [1] 0 0
Investigator Assessments of Overall Response Rate
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Duration of response
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
PFS (progression-free survival)
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [5] 0 0
Complete Response (CR) Rate
Timepoint [5] 0 0
Up to 30 months
Secondary outcome [6] 0 0
Change in scores of patient reported outcomes on EORTC QLQ-C30
Timepoint [6] 0 0
Up to 30 months
Secondary outcome [7] 0 0
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [7] 0 0
Up to 30 months
Secondary outcome [8] 0 0
Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV)
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Cemiplimab PK: Peak concentrations (Cmax) (SC)
Timepoint [9] 0 0
Up to 24 months
Secondary outcome [10] 0 0
Cemiplimab PK: Pre-infusion concentration (trough)
Timepoint [10] 0 0
Up to 24 months
Secondary outcome [11] 0 0
Cemiplimab PK: Time of end-of-infusion (teoi)
Timepoint [11] 0 0
Up to 24 months
Secondary outcome [12] 0 0
Cemiplimab PK: Time to peak concentration (tmax) (SC)
Timepoint [12] 0 0
Up to 24 months
Secondary outcome [13] 0 0
Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose
Timepoint [13] 0 0
Up to 24 months
Secondary outcome [14] 0 0
Cemiplimab PK: Absolute bioavailability after SC administration
Timepoint [14] 0 0
Up to 24 months
Secondary outcome [15] 0 0
Anti-cemiplimab antibodies
Timepoint [15] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
Key

- 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 and 4 only)

- Surgical or radiological treatment of lesions contraindicated

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [3] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
Germany
State/province [17] 0 0
Baden-Württemberg
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Niedersachsen
Country [20] 0 0
Germany
State/province [20] 0 0
Nordrhein-Westfalen
Country [21] 0 0
Germany
State/province [21] 0 0
Sachsen
Country [22] 0 0
Germany
State/province [22] 0 0
Schleswig-Holstein
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Gera

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

Ethics approval
Ethics application status

Summary
Brief summary
To estimate the clinical benefit of cemiplimab monotherapy for patients with metastatic
(nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with
unresectable locally advanced CSCC (Group 2), or with advanced CSCC [metastatic (nodal or
distal) or unresectable locally advanced] treated (Group 4) as measured by overall response
rate (ORR), according to central review.
Trial website
https://clinicaltrials.gov/show/NCT02760498
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 Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
clinicaltrials@regeneron.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02760498