Ovarian Cancer Clinical Trial
A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
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)
Eligibility Criteria
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)
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There are 27 Locations for this study
Los Angeles California, 90095, United States
San Diego California, 92093, United States
Aurora Colorado, 80045, United States
Sarasota Florida, 34232, United States
Boston Massachusetts, 02114, United States
New York New York, 10016, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37203, United States
Seattle Washington, 98107, United States
Innsbruck , 6020, Austria
Brussels , 1200, Belgium
Ghent , 9000, Belgium
Leuven , 3000, Belgium
Dresden , 01307, Germany
Essen , 45136, Germany
Mannheim , 68167, Germany
Bologna , 40138, Italy
Naples , 80131, Italy
Rome , 00168, Italy
Cordoba Andalusia, 14004, Spain
Barcelona , 08035, Spain
Madrid , 28027, Spain
Madrid , 28046, Spain
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