Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
Condition: Advanced Solid Tumors; Head and Neck Cancer; Pancreatic Cancer; Ovarian Cancer; Renal Cell Carcinoma; Malignant Glioma; Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Renal Cell; Glioma
Intervention: Cabiralizumab; Nivolumab
Intervention description: Solution for IV administration; Solution for IV administration
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid
      tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have at least one measurable lesion at baseline by computed tomography
             (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid
             Tumors (RECIST) v1.1 criteria.

          -  Patients must have had progressive disease on, after, or refused, appropriate approved
             therapy for their tumor type.

          -  Patients must have histologically or cytologically confirmed solid tumor that is
             locally recurrent or metastatic and has progressed following standard treatment or is
             not appropriate for standard treatment

          -  Understand and sign an Institutional review board/Independent ethics committee
             (IRB/IEC)-approved informed consent form (ICF) prior to any study-specific evaluation

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Willing and able to comply with all study procedures

        Exclusion Criteria:

          -  Current or history of clinically significant muscle disorders (e.g., myositis), recent
             unresolved muscle injury, or any condition known to elevate serum creatine kinase (CK)
             levels

          -  Decreased cardiac function with New York Heart Association (NYHA) > Class 2

          -  Uncontrolled or significant heart disorder such as unstable angina

          -  Significant abnormalities on electrocardiogram (ECG) at screening. Fridericia's
             correction formula for QT interval (QTcF) > 450 msec for males or > 470 msec for
             females at screening

          -  History of anti-drug antibodies, severe allergic, anaphylactic, or other
             infusion-related reaction to a previous biologic agent

          -  Positive test for latent tuberculosis (TB) at screening (Quantiferon test) or evidence
             of active TB

          -  Patients with abnormal serum chemistry values, which in the opinion of the
             Investigator is considered to be clinically significant, will be excluded from the
             study

          -  Lack of peripheral venous or central venous access or any condition that would
             interfere with drug administration or collection of study samples

          -  Any uncontrolled medical condition or psychiatric disorder which, in the opinion of
             the Investigator, would pose a risk to patient safety or interfere with study
             participation or interpretation of individual patient results

          -  Pregnant or breastfeeding

          -  Current unresolved infection or history of chronic, active, clinically significant
             infection (viral, bacterial, fungal, or other) which, in the opinion of the
             Investigator, would preclude the patient from exposure to a biologic agent or pose a
             risk to patient safety

          -  Prior exposure to any colony stimulating factor 1 receptor (CSF1R) pathway inhibitors