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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03198130

Enrollment

Registered

2017-06-23

Start date

2017-07-03

Completion date

2020-02-21

Last updated

2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DRUGREGN2810

Intravenous (IV) use

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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/

Design outcomes

Primary

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

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

Countries

South Korea, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026