Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

Summary

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

Keywords

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

Eligibility

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)

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • Swedish Cancer Institute accepting new patients
    Seattle Washington 98107 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT04042116
Phase
Phase 1/2
Study Type
Interventional
Last Updated