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)

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)

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

Study Overview

• Status: Completed
• Conditions: Recurrent Squamous Cell Carcinoma of Head; Recurrent Squamous Cell Carcinoma of Neck; Metastatic Squamous Cell Carcinoma of Head; Metastatic Squamous Cell Carcinoma Neck
• Intervention / Treatment: Drug: REGN2810

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University
  • Seoul, Korea, Republic of, 03722
    • Yonsei University College of Medicine, Severence Hospital
• United Kingdom
  • Birmingham, United Kingdom
    • University Birmingham
  • London, United Kingdom
    • Guy's and St. Thomas' NHS Foundation Trust
  • London, United Kingdom
    • Royal Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. 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.
2. 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
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
4. Adequate hepatic function
5. Adequate renal function
6. Adequate bone marrow function
7. Provide signed informed consent
8. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria will apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: REGN2810; REGN2810 administered IV over a 30 minute infusion	Drug: REGN2810; Intravenous (IV) use; Other Names: Libtayo; cemiplimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
Concentrations of REGN2810 in serum	Up to 54 weeks
Anti-REGN2810 antibody levels	Up to 54 weeks
The overall response rate (ORR) in patients treated with REGN2810	Up to 54 weeks
The progression-free survival (PFS) in patients treated with REGN2810	Up to 54 weeks

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2017
• Primary Completion (ACTUAL): June 27, 2019
• Study Completion (ACTUAL): February 21, 2020

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (ACTUAL): June 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Squamous Cell; Carcinoma; Recurrence; Carcinoma, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1655; 2016-004029-18 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes