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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02760498
Registration number
NCT02760498
Ethics application status
Date submitted
8/04/2016
Date registered
3/05/2016
Date last updated
13/12/2023
Titles & IDs
Public title
Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
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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
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Secondary ID [1]
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2016-000105-36
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Secondary ID [2]
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R2810-ONC-1540
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cutaneous Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - cemiplimab
Experimental: Group 1 - Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously (IV) every 2 weeks (Q2W).
Experimental: Group 2 - Patients with unresectable locally advanced CSCC. Cemiplimab administered IV Q2 weeks.
Experimental: Group 3 - Patients with metastatic CSCC to distant sites or lymph nodes. Cemiplimab administered IV Q3 weeks.
Experimental: Group 4 - Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered IV Q4 weeks.
Experimental: Group 6 - Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) who received cemiplimab IV Q3W for at least 27 weeks without experiencing disease progression, will have the option to receive cemiplimab by subcutaneous (SC) injection Q3W (first 12 patients) or Q6W (next = 6 patients) basis.
Treatment: Drugs: cemiplimab
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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Groups 1, 3, 4, and 6: Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to determine ORR. Group 2: Clinical response criteria will be used to determine ORR
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Timepoint [1]
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30 months
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Secondary outcome [1]
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Investigator Assessments of ORR
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Assessment method [1]
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Groups 1-4, and 6
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Timepoint [1]
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Up to 30 months
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Secondary outcome [2]
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Duration of response
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Assessment method [2]
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Groups 1-4, and 6
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Timepoint [2]
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Up to 30 months
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Secondary outcome [3]
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PFS (progression-free survival)
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Assessment method [3]
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Groups 1-4, and 6
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Timepoint [3]
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Up to 30 months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Groups 1-4, and 6
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Timepoint [4]
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Up to 30 months
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Secondary outcome [5]
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Complete Response (CR) Rate
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Assessment method [5]
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Groups 1-4, and 6
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Timepoint [5]
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Up to 30 months
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Secondary outcome [6]
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Change in scores of patient reported outcomes on EORTC QLQ-C30
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Assessment method [6]
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Except Group 6
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Timepoint [6]
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Up to 30 months
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Secondary outcome [7]
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Incidence of Treatment Emergent Adverse Events (TEAEs)
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Assessment method [7]
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Timepoint [7]
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Up to 30 months
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Secondary outcome [8]
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Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV)
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Assessment method [8]
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Timepoint [8]
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Up to 24 months
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Secondary outcome [9]
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Cemiplimab PK: Peak concentrations (Cmax) (SC)
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Assessment method [9]
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Timepoint [9]
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Up to 24 months
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Secondary outcome [10]
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Cemiplimab PK: Pre-infusion concentration (Ctrough)
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Assessment method [10]
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Timepoint [10]
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Up to 24 months
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Secondary outcome [11]
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Cemiplimab PK: Time of end-of-infusion (teoi)
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Assessment method [11]
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Timepoint [11]
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Up to 24 months
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Secondary outcome [12]
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Cemiplimab PK: Time to peak concentration (tmax) (SC)
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Assessment method [12]
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Timepoint [12]
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Up to 24 months
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Secondary outcome [13]
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Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose
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Assessment method [13]
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Timepoint [13]
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Up to 24 months
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Secondary outcome [14]
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Cemiplimab PK: Absolute bioavailability after SC administration
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Assessment method [14]
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Timepoint [14]
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Up to 24 months
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Secondary outcome [15]
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Anti-cemiplimab antibodies
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Assessment method [15]
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Timepoint [15]
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Up to 30 months
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Secondary outcome [16]
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Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR
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Assessment method [16]
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Group 6
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Timepoint [16]
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Up to 30 months
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Secondary outcome [17]
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IHC assessment of correlation between PD-L1 and DOR
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Assessment method [17]
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Group 6
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Timepoint [17]
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Up to 30 months
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Secondary outcome [18]
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IHC assessment of correlation between PD-L1 and PFS
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Assessment method [18]
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Group 6
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Timepoint [18]
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Up to 30 months
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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, 4, and 6)
- Surgical or radiological treatment of lesions contraindicated
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/10/2023
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Sample size
Target
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Accrual to date
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Final
432
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Gosford Hospital - Gosford
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Recruitment hospital [3]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [5]
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Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [7]
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Adelaide Cancer Centre - Kurralta Park
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Recruitment hospital [8]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [9]
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Border Medical Oncology - Wodonga
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Recruitment hospital [10]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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- Garran
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Recruitment postcode(s) [2]
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- Gosford
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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- Waratah
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Recruitment postcode(s) [5]
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4029 - Herston
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Recruitment postcode(s) [6]
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- Woolloongabba
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Recruitment postcode(s) [7]
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5037 - Kurralta Park
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Recruitment postcode(s) [8]
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3000 - Melbourne
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Recruitment postcode(s) [9]
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- Wodonga
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Recruitment postcode(s) [10]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Illinois
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United States of America
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Kentucky
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Massachusetts
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Michigan
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Missouri
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Nebraska
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Utah
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Rio Grande Do Sul
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Curitiba
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Nord
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Paris
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Schleswig-Holstein
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Gera
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Athens
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Campania
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Italy
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L'Aquila
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Italy
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Milan
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Roma
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Cordoba
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Madrid
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Santander
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with:
metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable
locally advanced CSCC
Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients
with advanced CSCC (metastatic [nodal or distant] or locally advanced treated with cemiplimab
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02760498
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trial Management
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Address
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Regeneron Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02760498
Download to PDF