A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
NCT ID: NCT04042116
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1/PHASE2
227 participants
INTERVENTIONAL
2019-07-29
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1b: Dose Escalation
\- Up to 50 patients with advanced solid tumor
Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Phase 1b: Food Effect Cohort
\- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
Lucitanib
Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.
Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Phase 2: Expansion Cohort - Endometrial Cancer
* Recurrent endometrial carcinoma at least 1 prior platinum-based chemotherapy regimen
* Up to 10 patients who have progressed on treatment with 1 prior PD-(L)1 inhibitor administered as monotherapy will be allowed to enroll
Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.
Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Phase 2: Expansion Cohort - Ovarian Cancer
* Recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma
* At least 2 prior chemotherapy regimens which at least 1 must have been platinum-doublet chemotherapy
* Up to 10 subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma who have progressed within 6 months after completing first-line platinum-based chemotherapy will be allowed to enroll
Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.
Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Phase 2: Expansion Cohort - Clear Cell Cancer
* Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin
* At least 1 prior platinum- and taxane-based chemotherapy regimen
Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.
Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Phase 2: Expansion Cohort - Cervical Cancer
* Persistent or recurrent cervix cancer of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma histology
* At least 1 prior regimen of platinum-based chemotherapy, with or without bevacizumab, for metastatic disease
Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.
Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Interventions
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Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Lucitanib
Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.
Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.
Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Clovis Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Erika Hamilton, MD
Role: PRINCIPAL_INVESTIGATOR
Tennessee Oncology
Nicole Concin, MD
Role: PRINCIPAL_INVESTIGATOR
KEM Kliniken Essen Mitte Evang. Huyssens-Stiftung
Locations
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UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
UC San Diego Moores Cancer Center
San Diego, California, United States
Anschutz Cancer Pavilion
Aurora, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
NYU Langone Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University School of Medicine
Durham, North Carolina, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
Swedish Cancer Institute
Seattle, Washington, United States
Medical University of Innsbruck
Innsbruck, , Austria
Saint Luc Univerisity Hospital
Brussels, , Belgium
University Hospital Ghent
Ghent, , Belgium
University Hospitals Leuven, Campus Gasthuisberg
Leuven, , Belgium
University Hospital Carl Gustav Carus
Dresden, , Germany
Kliniken Essen-Mitte
Essen, , Germany
University Hospital Mannhein
Mannheim, , Germany
Polyclinic S. Orsola-Malpighi
Bologna, , Italy
National Cancer Institute -IRCCS "Fondazione G. Pascale
Naples, , Italy
Foundation IRCCS Hospital Agostino Gemelli
Rome, , Italy
University Hospital Reina Sofia
Córdoba, Andalusia, Spain
University Hospital Vall d'Hebron
Barcelona, , Spain
Navarra University Clinic
Madrid, , Spain
La Paz University Hospital
Madrid, , Spain
Countries
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Other Identifiers
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ENGOT-GYN3/AGO/LIO
Identifier Type: OTHER
Identifier Source: secondary_id
CO-3810-101
Identifier Type: -
Identifier Source: org_study_id