This study is in progress, not accepting new patients

Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

a study on Lung Cancer Solid Tumor Head and Neck Cancer Pancreatic Cancer Ovarian Cancer Kidney Cancer Renal Cell Carcinoma Glioma

Summary

for people ages 18 years and up (full criteria)
at UC Davis UCLA UCSD UCSF
study started
estimated completion

Description

Summary

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

Official Title

A Phase 1a/1b Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

Keywords

Advanced Solid Tumors, Including But Not Limited to Lung Cancer Head and Neck Cancer Pancreatic Cancer Ovarian Cancer Renal Cell Carcinoma Malignant Glioma Pancreatic Neoplasms Head and Neck Neoplasms Carcinoma, Renal Cell Glioma Nivolumab Sargramostim FPA008 BMS-936558

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria.
  • Patients must have had progressive disease on, after, or refused, appropriate approved therapy for their tumor type.
  • Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
  • ECOG performance status of 0 or 1
  • Willing and able to comply with all study procedures

You CAN'T join if...

  • Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels
  • Decreased cardiac function with NYHA > Class 2
  • Uncontrolled or significant heart disorder such as unstable angina
  • Significant abnormalities on ECG at screening. 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 CSF1R pathway inhibitors

Locations

  • Moores UC San Diego Cancer Center
    La Jolla California 92093 United States
  • UC Davis Comprehensive Cancer Center
    Sacramento California 95817 United States
  • University of California, San Francisco
    San Francisco California 94143 United States
  • UCLA Hematology/Oncology- Santa Monica
    Santa Monica California 90404 United States
  • Sarcoma Oncology Research Center
    Santa Monica California 90403 United States
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Five Prime Therapeutics, Inc.
ID
NCT02526017
Phase
Phase 1
Study Type
Interventional
Last Updated