Clinical Trial 18587

Cancer Type: Head & Neck
Interventions:REGN2810

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Nikhil Khushalani

Overview

Study Title

A Phase 2 Study of REGN2810, A Fully Human Monoclonal Antibody to Programmed Death 1(PD-1), in Patients with Advanced Cutaneous Squamous Cell Carcinoma

Summary

The purpose of this study is to test the effects of REGN2810 (''study drug") in participants with advanced cutaneous squamous cell carcinoma (CSCC).

Objective

The primary objective of this study is to estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central review. The secondary objectives of the study are: To estimate ORR according to investigator review. To estimate the duration of response, progression-free survival (PFS), and overall survival (OS) by central and investigator review. To estimate the complete response (CR) rate by central review. To assess the safety and tolerability of REGN2810. To assess the pharmacokinetics (PK) of REGN2810 (at select sites only). To assess the immunogenicity of REGN2810. To assess the impact of REGN2810 on quality of life using EORTC QLQ-C30.

Inclusion Criteria

  • Eligible patients with metastatic cutaneous squamous cell carcinoma (CSCC) [Group 1] and unresectable locally advanced CSCC [Group 2].
  • Histologically confirmed diagnosis of invasive CSCC.
  • At least 1 lesion that is measurable by study criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (ECOG PS 1.
  • ≥18 years old.
  • Adequate hepatic, renal, and bone marrow function.
  • Ability to provide signed informed consent.
  • Ability and willingness to comply with scheduled visits, treatment plans, laboratory tests and other study-related procedures.
  • Anticipated life expectancy >12 weeks.
  • Group 2 only: Surgery must be deemed contraindicated in the opinion of a Mohs dermatologic surgeon, a head and neck surgeon, or plastic surgeon.
  • Group 2 only: Participants must be deemed as not appropriate for radiation therapy.
  • Additional criteria may apply.

  • 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 events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
  • Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
  • Prior treatment with other immune modulating agents, (a) within fewer than 4 weeks prior to the first dose of REGN2810, or (b) associated with immune-mediated adverse events greater than grade 1 within 90 prior or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune modulating include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
  • Untreated brain metastasis(es) that may be considered active.
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810.
  • Active infection requiring therapy, including infection with human immunodeficiency virus, or active infection with hepatitis B virus or hepatitis C virus.
  • History of pneumonitis within the last 5 years.
  • Grade ≥3 hypercalcemia at time of enrollment.
  • Any systemic anticancer treatment (chemotherapy, targeted systemic therapy, photodynamic therapy), investigational or standard of care, within 30 days of the initial administration of REGN2810 or planned to occur during the study period (Patients receiving bisphosphonates or denosumab are not excluded).
  • History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
  • Allergy or hypersensitivity to REGN2810 or to any excipients.
  • Women who are pregnant or breastfeeding.
  • Concurrent malignancy other than CSCC and/or history of malignancy other than CSCC within 3 years of date of first planned dose of REGN2810, with some exceptions..
  • Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the patient ineligible for participation.
  • Continued sexual activity in men or women of childbearing potential who are unwilling to practice highly effective contraception during the study and until 6 months after the last dose of study drug.
  • History of solid organ transplant (possible exception may apply for corneal transplant)
  • Prior treatment with a BRAF inhibitor.
  • Inability to undergo any contrast-enhanced radiologic response assessment.
  • Prior treatment with idelalisib.
  • Additional criteria may apply.