for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
completion around



This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)

Official Title

LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor


Advanced Solid Tumor, Gynecologic Cancer, lucitanib, nivolumab, antineoplastic agents immunological, antineoplastic agents, tyrosine kinase inhibitors, gynecologic neoplasms, checkpoint inhibitor, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, clear cell cancer, cervical cancer, PD-1 inhibitor, Immuno-oncology, Neoplasms


For people ages 18 years and up

General Inclusion Criteria:

  • ≥ 18 years of age
  • Adequate organ function
  • Life expectancy ≥ 3 months
  • Women of childbearing potential must have a negative serum pregnancy test
  • Advanced/metastatic solid tumor (Phase 1b)
  • Availability of tumor tissue at screening
  • ECOG performance status of 0 to 1
  • Measurable disease (RECIST v1.1) (Phase 2)
  • Advanced, recurrent, or metastatic gynecological solid tumor (Phase 2)
  • Willing and able to fast, and to eat a high-fat breakfast (Food Effect)

General Exclusion Criteria:

  • Prior treatment with lucitanib
  • Active second malignancy
  • Active central nervous system brain metastases
  • Pre-existing duodenal stent or any gastrointestinal disorder
  • Known history of HIV or AIDs; positive result of hepatitis B or C viruses
  • Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis
  • Active, known or suspected autoimmune disease (eg, autoimmune hepatitis)
  • Condition requiring systemic treatment with corticosteroids or other immune suppressive medications
  • Unstable or uncontrolled hypertension (BP ≥ 140/90 mmHg)
  • Prior treatment with a VEGFR-tyrosine kinase inhibitor (Phase 2)


  • UC San Diego Moores Cancer Center
    San Diego California 92093 United States
  • UCLA Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States


currently not accepting new patients, but might later
Start Date
Completion Date
Clovis Oncology, Inc.
Phase 1/2 research study
Study Type
Expecting 227 study participants
Last Updated