Back to results

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)

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

REGN2810

About this trial

This is an interventional treatment trial for Recurrent Squamous Cell Carcinoma of Head

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University
Yonsei University College of Medicine, Severence Hospital
Samsung Medical Center
University Birmingham
Guy's and St. Thomas' NHS Foundation Trust
Royal Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REGN2810

Arm Description

REGN2810 administered IV over a 30 minute infusion

Outcomes

Primary Outcome Measures

Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.

Secondary Outcome Measures

Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment

Number of participants with treatment-related adverse events

Concentrations of REGN2810 in serum

Anti-REGN2810 antibody levels

The overall response rate (ORR) in patients treated with REGN2810

The progression-free survival (PFS) in patients treated with REGN2810

Full Information

NCT ID

NCT03198130

First Posted

June 19, 2017

Last Updated

March 17, 2020

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03198130

Brief Title

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)

Official Title

An Exploratory Tumor Biopsy-Driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Immunomodulatory Treatment-Naïve Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck Receiving REGN2810 (Anti-PD-1)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

July 3, 2017 (Actual)

Primary Completion Date

June 27, 2019 (Actual)

Study Completion Date

February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REGN2810

Arm Type

Experimental

Arm Description

REGN2810 administered IV over a 30 minute infusion

Intervention Type

Drug

Intervention Name(s)

REGN2810

Other Intervention Name(s)

cemiplimab, Libtayo

Intervention Description

Intravenous (IV) use

Primary Outcome Measure Information:

Title

Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.

Time Frame

At baseline and during REGN2810 treatment up to week 24

Secondary Outcome Measure Information:

Title

Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment

Time Frame

At baseline and during REGN2810 treatment up to week 24

Title

Number of participants with treatment-related adverse events

Time Frame

Up to 54 weeks

Title

Concentrations of REGN2810 in serum

Time Frame

Up to 54 weeks

Title

Anti-REGN2810 antibody levels

Time Frame

Up to 54 weeks

Title

The overall response rate (ORR) in patients treated with REGN2810

Time Frame

Up to 54 weeks

Title

The progression-free survival (PFS) in patients treated with REGN2810

Time Frame

Up to 54 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Seoul National University

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Yonsei University College of Medicine, Severence Hospital

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

University Birmingham

City

Birmingham

Country

United Kingdom

Facility Name

Guy's and St. Thomas' NHS Foundation Trust

City

London

Country

United Kingdom

Facility Name

Royal Cancer Hospital

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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)

We'll reach out to this number within 24 hrs