History of Changes for Study: NCT02760498

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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Study Record Versions

Version	Submitted Date	Changes
1	April 29, 2016	None (earliest Version on record)
2	July 14, 2016	Contacts/Locations, Study Status and Study Design
3	July 19, 2016	Contacts/Locations and Study Status
4	August 19, 2016	Study Status and Contacts/Locations
5	September 20, 2016	Contacts/Locations and Study Status
6	November 2, 2016	Study Status and Contacts/Locations
7	December 1, 2016	Study Status and Contacts/Locations
8	January 11, 2017	Study Status, Contacts/Locations and Eligibility
9	February 15, 2017	Study Status and Contacts/Locations
10	April 12, 2017	Study Status and Contacts/Locations
11	June 28, 2017	Contacts/Locations and Study Status
12	October 2, 2017	Outcome Measures, Arms and Interventions, Study Status, Eligibility, Study Design and Study Description
13	February 15, 2018	Contacts/Locations and Study Status
14	May 9, 2018	Study Status, Contacts/Locations and Outcome Measures
15	January 10, 2019	Arms and Interventions, Study Status, Outcome Measures, Oversight, Contacts/Locations, Eligibility, Study Design and Study Description
16	August 5, 2019	Contacts/Locations, Study Status, Outcome Measures and Study Identification
17	May 18, 2020	Outcome Measures, Study Status, Arms and Interventions, Contacts/Locations, Eligibility, Study Design, Conditions and Study Description
18	July 15, 2020	Study Status and Contacts/Locations
19	November 9, 2020	Contacts/Locations and Study Status
20	January 25, 2021	Contacts/Locations and Study Status
21	December 23, 2021	Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Study Design, Eligibility, Arms and Interventions and Study Description
22	January 4, 2023	Study Status
23	November 17, 2023	Recruitment Status and Study Status
24	December 12, 2023	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	R2810-ONC-1540
Brief Title:	Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Official 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 IDs:

Study Status


Record Verification:	April 2016
Overall Status:	Recruiting
Study Start:	March 2016
Primary Completion:	May 2019 [Anticipated]
Study Completion:	May 2019 [Anticipated]

First Submitted:	April 8, 2016
First Submitted that Met QC Criteria:	April 29, 2016
First Posted:	May 3, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	April 29, 2016
Last Update Posted:	May 3, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Regeneron Pharmaceuticals
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description


Brief Summary:	To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central review.
Detailed Description:

Conditions


Conditions:	Advanced Cutaneous Squamous Cell Carcinoma
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Single Group Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	129 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Group 1 Patients with metastatic CSCC: to distant sites or lymph nodes	Drug: REGN2810
Experimental: Group 2 Patients with unresectable locally advanced CSCC	Drug: REGN2810

Outcome Measures


Primary Outcome Measures:
1.	Overall Response Rate [ Time Frame: During the 12 treatment cycles (96 weeks) ] Overall Response Rate as determined by RECIST 1.1 for Group 1 and/or assessed per composite response criteria (Group 2)
Secondary Outcome Measures:
1.	Duration of response [ Time Frame: From date of treatment until date of first documented progression or date of death, assessed up to 30 months ]
2.	PFS (progression-free survival) [ Time Frame: From date of treatment until date of death, assessed up to 30 months ]
3.	Overall Survival [ Time Frame: From date of treatment until date of death, assessed up to 30 months ]
4.	Change in scores of patient reported outcomes on EORTC QLQ-C30 [ Time Frame: From date of treatment until date of first documented progression or date of death, assessed up to 24 months ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Key Inclusion Criteria: 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 externally visible CSCC lesions (Group 2 only) Surgical or radiological treatment of lesions contraindicated 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 REGN2810. Examples of immune modulating 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 REGN2810 Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus History of 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 may apply

Contacts/Locations


Central Contact Person:	Clinical Trials Administrator Email: clinicaltrials@regeneron.com
Study Officials:	Clinical Trial Management Study Director Regeneron Pharmaceuticals
Locations:	United States, Florida
	[Recruiting] Tampa, Florida, United States
	United States, Missouri
	[Not yet recruiting] St. Louis, Missouri, United States

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: