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)

Phase 1

Completed

• Conditions: Recurrent Squamous Cell Carcinoma of Neck; Metastatic Squamous Cell Carcinoma of Head; Recurrent Squamous Cell Carcinoma of Head; Metastatic Squamous Cell Carcinoma Neck
• Interventions: Drug: REGN2810

• Registration Number: NCT03198130
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Study Start: 2017-07-03
• Primary Completion: 2019-06-27
• Study Completion: 2020-02-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REGN2810	REGN2810	REGN2810 administered IV over a 30 minute infusion

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (6)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of

Yonsei University College of Medicine, Severence Hospital; 🇰🇷 Seoul, Korea, Republic of

University Birmingham; 🇬🇧 Birmingham, United Kingdom

Royal Cancer Hospital; 🇬🇧 London, United Kingdom

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Guy's and St. Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom