A Phase I Study of Varlilumab plus Nivolumab Immunotherapy in Patients with Advanced Solid Tumors

Full Title

A Phase I/II Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 antibody (Varlilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors (Amendment 6: 28-NOV-2016)


The purpose of this study is to assess the safety of combining two drugs, varlilumab and nivolumab, in patients with advanced solid tumors that have continued to grow despite treatment. Varlilumab is an investigational drug that binds to a protein on immune cells called CD27, which makes the immune system stronger. Nivolumab is a form of immunotherapy. It works by attaching to and blocking a molecule called PD-1, which shuts down the immune response. It is hoped that by binding to these proteins, this drug combination can activate the immune system and enhance the body’s ability to detect and destroy cancer cells.

Nivolumab is approved for treating several types of cancer; its use in this study is considered investigational. Varilumab is an investigational drug. Both nivolumab and varlilumab are given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced solid tumor which has continued to grow despite treatment. Patients must have one of the following solid tumors: melanoma, non-small cell lung cancer, colorectal cancer, ovarian cancer, or head and neck squamous cell cancer.
  • Up to five prior regimens of cancer treatment for advanced disease are allowed.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Margaret Callahan at 646-888-3579.