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)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Recurrent Squamous Cell Carcinoma of Head; Metastatic Squamous Cell Carcinoma Neck; Metastatic Squamous Cell Carcinoma of Head; Recurrent Squamous Cell Carcinoma of Neck

Treatments: Drug: REGN2810

Study type: Interventional

Funder types: Industry

Identifiers

NCT03198130

R2810-ONC-1655

2016-004029-18 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria will apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

REGN2810

Experimental group

Description:

REGN2810 administered IV over a 30 minute infusion

Treatment:

Drug: REGN2810