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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02760498
Registration number
NCT02760498
Ethics application status
Date submitted
8/04/2016
Date registered
3/05/2016
Date last updated
28/05/2025
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
Experimental: Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W - Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Experimental: Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W - Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Experimental: Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W - Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Experimental: Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W - Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
Experimental: Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W - Participants received a single subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Experimental: Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W - Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
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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) by Independent Central Review
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Assessment method [1]
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ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
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Timepoint [1]
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Up to 108 weeks
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Secondary outcome [1]
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ORR by Investigator Assessment
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Assessment method [1]
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ORR was defined as percentage of participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm \<1 cm. -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
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Timepoint [1]
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Up to 108 weeks
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Secondary outcome [2]
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Duration of Response (DOR) by Independent Central Review
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Assessment method [2]
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DOR was measured from the time measurement criteria were first met for CR/PR, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of = 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
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Timepoint [2]
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Up to approximately 65 months (treatment period + follow-up including survival follow-up)
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Secondary outcome [3]
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DOR by Investigator Assessment
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Assessment method [3]
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DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of = 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
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Timepoint [3]
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Up to approximately 65 months (treatment period + follow-up including survival follow-up)
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Secondary outcome [4]
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Progression-Free Survival (PFS) by Independent Central Review
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Assessment method [4]
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PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of = 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
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Timepoint [4]
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Up to approximately 65 months (treatment period + follow-up including survival follow-up)
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Secondary outcome [5]
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PFS by Investigator Assessment
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Assessment method [5]
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PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of = 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
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Timepoint [5]
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Up to approximately 65 months (treatment period + follow-up including survival follow-up)
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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OS was measured from start of treatment until death due to any cause.
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Timepoint [6]
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Up to approximately 65 months (treatment period + follow-up including survival follow-up)
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Secondary outcome [7]
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Complete Response (CR) Rate by Independent Central Review
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Assessment method [7]
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CR rate was defined as percentage of participants with BOR of CR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm \<1 cm. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions.
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Timepoint [7]
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Up to 108 weeks
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Secondary outcome [8]
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
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Assessment method [8]
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EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.
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Timepoint [8]
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Baseline, Up to Cycle 12 Day 1 (Week 89)
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Secondary outcome [9]
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Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
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Assessment method [9]
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [9]
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Up to 108 weeks plus 105 days (5 half-lives)
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Secondary outcome [10]
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Peak Concentration (Cmax) of Cemiplimab
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Assessment method [10]
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Timepoint [10]
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Up to approximately 43 months
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Secondary outcome [11]
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Trough Concentration (Ctrough) of Cemiplimab
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Assessment method [11]
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Timepoint [11]
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Up to approximately 43 months
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Secondary outcome [12]
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Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies
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Assessment method [12]
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Timepoint [12]
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Up to approximately 43 months
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Secondary outcome [13]
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ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays
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Assessment method [13]
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ORR was defined as percentage of participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by immunohistochemistry (IHC). -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
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Timepoint [13]
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Up to 108 weeks
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Secondary outcome [14]
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DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays
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Assessment method [14]
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DOR was measured from the time measurement criteria are first met for CR/PR, as defined in Outcome Measure 13, whichever was recorded first, until the first date of recurrent or PD or death due to any cause in participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by IHC. -PD: increase of = 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
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Timepoint [14]
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Up to approximately 65 months (treatment period + follow-up including survival follow-up)
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Secondary outcome [15]
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PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays
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Assessment method [15]
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PFS was measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause. Expression level of PD-L1 was assessed in tumor biopsy samples. -PD: increase of = 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
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Timepoint [15]
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Up to approximately 65 months (treatment period + follow-up including survival follow-up)
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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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California
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Colorado
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Florida
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Illinois
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Kentucky
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United States of America
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New York
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Utah
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Brazil
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Rio Grande Do Sul
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Brazil
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Curitiba
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Brazil
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Ipatinga
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Brazil
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Lages
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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France
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Nord
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France
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Bobigny
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France
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Bordeaux
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France
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Dijon
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France
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Grenoble
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France
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Marseille
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France
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Nantes
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France
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Paris
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France
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Pierre Bénite
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France
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Villejuif
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Gera
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Greece
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Athens
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Italy
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Campania
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Italy
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Veneto
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Italy
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Brescia
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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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Italy
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Roma
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Spain
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Barelona
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Spain
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Cataluna
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Santander
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Spain
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State/province [54]
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) Cutaneous Squamous Cell Carcinoma (CSCC), or unresectable locally advanced CSCC.
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Trial website
https://clinicaltrials.gov/study/NCT02760498
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Trial related presentations / publications
Rischin D, Khushalani NI, Schmults CD, Guminski A, Chang ALS, Lewis KD, Lim AM, Hernandez-Aya L, Hughes BGM, Schadendorf D, Hauschild A, Thai AA, Stankevich E, Booth J, Yoo SY, Li S, Chen Z, Okoye E, Chen CI, Mastey V, Sasane M, Lowy I, Fury MG, Migden MR. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. J Immunother Cancer. 2021 Aug;9(8):e002757. doi: 10.1136/jitc-2021-002757. Paccaly AJ, Migden MR, Papadopoulos KP, Yang F, Davis JD, Rippley RK, Lowy I, Fury MG, Stankevich E, Rischin D. Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis. Adv Ther. 2021 May;38(5):2365-2378. doi: 10.1007/s12325-021-01638-5. Epub 2021 Mar 25. Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing. J Immunother Cancer. 2020 Jun;8(1):e000775. doi: 10.1136/jitc-2020-000775. Migden MR, Khushalani NI, Chang ALS, Lewis KD, Schmults CD, Hernandez-Aya L, Meier F, Schadendorf D, Guminski A, Hauschild A, Wong DJ, Daniels GA, Berking C, Jankovic V, Stankevich E, Booth J, Li S, Weinreich DM, Yancopoulos GD, Lowy I, Fury MG, Rischin D. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4. Epub 2020 Jan 14. Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
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Contacts
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Regeneron Pharmaceuticals
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/98/NCT02760498/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/98/NCT02760498/SAP_001.pdf
Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT02760498
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