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)

View Eligibility Criteria

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)

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

227

Study ID:

NCT04042116

Recruitment Status:

Suspended

Sponsor:

Clovis Oncology, Inc.

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There are 27 Locations for this study

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UCLA Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States
UC San Diego Moores Cancer Center
San Diego California, 92093, United States
Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
NYU Langone Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke University School of Medicine
Durham North Carolina, 27710, United States
Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Magee-Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Swedish Cancer Institute
Seattle Washington, 98107, United States
Medical University of Innsbruck
Innsbruck , 6020, Austria
Saint Luc Univerisity Hospital
Brussels , 1200, Belgium
University Hospital Ghent
Ghent , 9000, Belgium
University Hospitals Leuven, Campus Gasthuisberg
Leuven , 3000, Belgium
University Hospital Carl Gustav Carus
Dresden , 01307, Germany
Kliniken Essen-Mitte
Essen , 45136, Germany
University Hospital Mannhein
Mannheim , 68167, Germany
Polyclinic S. Orsola-Malpighi
Bologna , 40138, Italy
National Cancer Institute -IRCCS "Fondazione G. Pascale
Naples , 80131, Italy
Foundation IRCCS Hospital Agostino Gemelli
Rome , 00168, Italy
University Hospital Reina Sofia
Cordoba Andalusia, 14004, Spain
University Hospital Vall d'Hebron
Barcelona , 08035, Spain
Navarra University Clinic
Madrid , 28027, Spain
La Paz University Hospital
Madrid , 28046, Spain

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

227

Study ID:

NCT04042116

Recruitment Status:

Suspended

Sponsor:


Clovis Oncology, Inc.

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