Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

Not Recruiting

Trial ID: NCT02383212


This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.

Official Title

A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies

Stanford Investigator(s)

Seema Nagpal, MD
Seema Nagpal, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Reena Thomas, MD PhD
Reena Thomas, MD PhD

Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery

Scott G. Soltys, MD
Scott G. Soltys, MD

Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Key Inclusion Criteria:

   1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated
   progression of a solid tumor (non-lymphoma) with no alternative standard-of-care
   therapeutic option (certain exceptions may apply).

   2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors
   (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)

   3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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 events (irAEs). The following are not exclusionary:
   vitiligo, childhood asthma that has resolved, residual hypothyroidism that required
   only hormone replacement or psoriasis that does not require systemic treatment.

   2. Prior treatment with an agent that blocks the programmed death-1/ programmed
   death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)

   3. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to
   the first dose of cemiplimab. Examples of immune modulating agents include blockers of
   CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.

   4. Untreated brain metastasis(es) that may be considered active. Patients with previously
   treated brain metastases may participate provided they are stable (i.e., without
   evidence of progression by imaging for at least 6 weeks prior to the first dose of
   study treatment, and any neurologic symptoms have returned to baseline), and there is
   no evidence of new or enlarging brain metastases, and the patient does not require any
   systemic corticosteroids for management of brain metastases within 4 weeks prior to
   the first dose of cemiplimab (certain exceptions may apply).

   5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of cemiplimab

The information provided above is not intended to contain all considerations relevant to
potential participation in a clinical trial, therefore not all inclusion/ exclusion
criteria are listed.


radiation: Hypofractionated radiotherapy

drug: Cyclophosphamide

drug: Docetaxel

drug: Carboplatin

drug: GM-CSF

drug: Paclitaxel

drug: Pemetrexed

drug: Cemiplimab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

New Trial Alerts