A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
Reason given: Company decision
Key facts
- Where
- Aurora, Boston, Columbus, Durham, Los Angeles, Nashville, New York, Oklahoma City, Pittsburgh, San Diego, Sarasota, and Seattle, United StatesSee the 13 sites
- Phase
- Phase 1/2
Where in United States
- Anschutz Cancer PavilionAurora, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Ohio State University Wexner Medical CenterColumbus, United StatesNo longer taking part
- Duke University School of MedicineDurham, United StatesNo longer taking part
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, United StatesNo longer taking part
- Tennessee OncologyNashville, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- NYU Langone Laura and Isaac Perlmutter Cancer CenterNew York, United StatesNo longer taking part
- Stephenson Cancer CenterOklahoma City, United StatesNo longer taking part
- Magee-Womens Hospital of UPMCPittsburgh, United StatesNo longer taking part
- UC San Diego Moores Cancer CenterSan Diego, United StatesNo longer taking part
- Florida Cancer SpecialistsSarasota, United StatesNo longer taking part
- Swedish Cancer InstituteSeattle, United StatesNo longer taking part
Trial details
- Who runs it
- Clovis Oncology, Inc.
- Trial code
- NCT04042116
- Record updated
- 20 December 2022
- Original description
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)Read full original descriptionShow less
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
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)
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).