Open Actively Recruiting

A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

About

Brief 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)

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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)

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
20-002190
Category
Hematology-Oncology
Oncology
Contact
GINA KHACHATRIAN
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04042116
For detailed technical eligibility, visit ClinicalTrials.gov.