Overview
A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
Status:
Recruiting
Recruiting
Trial end date:
2024-01-01
2024-01-01
Target enrollment:
0
0
Participant gender:
All
All
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)Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Clovis Oncology, Inc.Collaborators:
Bristol-Myers Squibb
European Network of Gynaecological Oncological Trial Groups (ENGOT)Treatments:
Antineoplastic Agents
Nivolumab
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)