An Exploratory Tumor Biopsy-driven Study to Understand th... | NCT03198130

Studies
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)

NCT03198130

Sponsor

Regeneron Pharmaceuticals

Status

Completed

Last Update Posted

Mar 19, 2020Actual

Enrollment

33Actual

Phase

Phase 1

Conditions

Recurrent Squamous Cell Carcinoma of Head
Recurrent Squamous Cell Carcinoma of Neck
Metastatic Squamous Cell Carcinoma of Head
Metastatic Squamous Cell Carcinoma Neck

Interventions

REGN2810

Countries

South Korea
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2016-004029-18	EudraCT Number

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2017Actual

Primary Completion Date

Jun 27, 2019Actual

Completion Date

Feb 21, 2020Actual

First Submitted Date

Jun 19, 2017

First Submission Date that Met QC Criteria

Jun 21, 2017

First Posted Date

Jun 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2020

Last Update Posted Date

Mar 19, 2020Actual

Name	Class
Sanofi	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Label	Type	Description	Intervention Names
REGN2810	Experimental	REGN2810 administered IV over a 30 minute infusion	Drug: REGN2810

Name	Type	Description	Arm Group Labels	Other Names
REGN2810	Drug	Intravenous (IV) use	REGN2810	cemiplimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.		At baseline and during REGN2810 treatment up to week 24

Secondary Outcomes

Measure	Description	Time Frame
Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment		At baseline and during REGN2810 treatment up to week 24
Number of participants with treatment-related adverse events		Up to 54 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included.
Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Adequate hepatic function
Adequate renal function
Adequate bone marrow function
Provide signed informed consent
Willing and able to comply with clinic visits and study-related procedures

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 event (irAEs)
Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
Prior treatment with other immune modulating anti-cancer agents
Untreated or active brain metastases or spinal cord compression
Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria will apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University		Seoul		03080	South Korea
Yonsei University College of Medicine, Severence Hospital