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