Status:
SUSPENDED
A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
Lead Sponsor:
Clovis Oncology, Inc.
Collaborating Sponsors:
Bristol-Myers Squibb
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Advanced Solid Tumor
Gynecologic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- General
- ≥ 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
- 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)
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT04042116
Start Date
July 29 2019
End Date
January 1 2024
Last Update
December 20 2022
Active Locations (27)
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1
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
2
UC San Diego Moores Cancer Center
San Diego, California, United States, 92093
3
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
4
Florida Cancer Specialists
Sarasota, Florida, United States, 34232