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Patients With Selected Advanced Cancers Treatment Study

Clinical Trial Title: 
A phase 1a/1b study of FPA008 in combination with nivolumab in patients with selected advanced cancers.
Clinical Trial Protocol ID: 
15080305
Clinical Trial Investigator Name: 
Nicklas Pfanzelter, MD
Clinical Trial Protocol Description: 

This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced cancers.

Multiple cohorts for treatment:

NSCLC, pancreatic, renal, melanoma, ovarian, head and neck and malignant glioma cancers may qualify.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria.
    • Tumor sites used to satisfy this criterion must not have received any prior radiation therapy.
    • Sites for biopsy must be distinct from target lesions used for efficacy assessment.
  • Have had progressive disease on, or refused, appropriate approved therapy for their tumor type unless otherwise specified in the cohort specific criteria.
  • Have had prior focal radiotherapy completed at least 2 weeks before first dose of study drug administration.

You will be excluded from the study if any of the following criteria apply to you:

  • Have current or a history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
  • Have uncontrolled or significant heart disorder such as unstable angina.
  • Have had treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days prior to first dose of study drug administration or while on this study.
  • Have had prior exposure to any CSF1R pathway inhibitors.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Brain Tumors
Dermatology
Gastrointestinal Cancers
Genitourinary Cancers
Gynecologic Cancers
Head and Neck Cancer
Kidney and Urinary System Disorders
Liver, Biliary and Pancreatic Disorders
Lung and Chest Tumors
Melanoma and Soft Tissue
Sarcomas
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC