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Clinical Trial VICCPHI1359


A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors

Principal Investigator(s)

Emily Chan


  • Protocol No. VICCPHI1359
  • Open Date: 12/03/2013
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: To evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors.
  • Disease Sites: Breast; Pancreatic; Lung; Gastric/Gastroesophageal
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Ipilimumab; Nivolumab (BMS-936558)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01928394
  • Secondary Protocol No: CA209032


Patients are asked to take part in this research study because they have an advanced or metastatic solid tumor allowed on this study. The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) either as a single agent therapy or when combined with a drug called ipilimumab. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body-s immune system to work against tumor cells. An investigational drug is one that is not approved by the US Food and Drug Administration (FDA) or any other agency and is being studied and developed. Ipilimumab (Yervoy) is approved by the FDA, EMA (European Medicines Agency) and other health authorities for the treatment of metastatic melanoma. Ipilimumab is not approved by the FDA for treatment against this type of cancer and is also investigational. Ipilimumab is an antibody that acts against CTLA-4, a protein that turns off part of the immune system. An antibody against CTLA-4 can stop CTLA-4 from turning off the immune system, hopefully allowing an immune reaction to the cancer to continue. The body-s immune reaction may help the body to destroy cancer cells. The effectiveness of nivolumab or nivolumab combined with ipilimumab in select solid tumors will be determined by objective response rate (how many patients will have tumor shrinkage) to therapy in subjects who receive the investigational drug nivolumab or nivolumab combined with ipilimumab. About 360 subjects are expected to participate in this study, with approximately 70% of them in the North America (US), approximately 30% in Europe. About 16 patients will be enrolled at Vanderbilt. Even though patients may meet all the criteria for participation, it is possible that they will not be enrolled in this study. If patients are randomized (assigned by chance to a treatment arm) or assigned to an open treatment arm, the duration of their participation will depend on their response to treatment. After completing all study treatments or after the patient is withdrawn from treatment, they will be asked to continue with follow-up visits to monitor for side effects or potential benefits they may be experiencing from study treatment. (As described below under -Follow-Up- in Section 5, it may be necessary to gather additional information later, to further evaluate the safety or efficacy of the drug). The patient's total participation in this study from the time they have signed the informed consent form through to their last visit, including follow up visits, may be over one year (depending on how their cancer responds to treatment and how well they tolerate the treatment). This study is called a phase I/II study because it consists of a so-called -phase I- part and a -phase II- part. In general, Phase I studies investigate the safety and tolerability of a treatment at various dose levels, whereas Phase II studies assess the efficacy of a treatment at a given dose level. This study combines a Phase I part and a Phase II part. In the beginning of the study, patients are being randomized (assigned by chance, like flipping a coin) to either a Phase I part (here also called -safety evaluation phase), where they will be treated with nivolumab combined with ipilimumab, or a Phase II part, where they will be treated with nivolumab only. Once the dose level for the combination of nivolumab with ipilimumab has been confirmed, the Phase I part is completed and all newly enrolled patients from there on will be randomized to either the phase II part of the study with nivolumab combined with ipilimumab at the confirmed dose level, or to the phase II of nivolumab treatment only. The pharmaceutical company sponsoring this study is Bristol-Myers Squibb. The study doctor or hospital will be paid for the work they do by including patients in this study.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


For more information regarding BMS clinical trial participation, please visit
Inclusion Criteria:
• Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:
• Triple Negative Breast Cancer
• Gastric Cancer
• Pancreatic Cancer
• Small Cell Lung Cancer
• Bladder Cancer
• Subjects must have measurable disease
• Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Exclusion Criteria:
• Active brain metastases or leptomeningeal metastases
• Subjects with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
• Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited