Study Stopped
Company decision
A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
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
2 other identifiers
interventional
227
6 countries
27
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 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2019
Longer than P75 for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedStudy Start
First participant enrolled
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedDecember 20, 2022
December 1, 2022
3.9 years
July 19, 2019
December 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b)
Incidence of adverse events and clinical lab abnormalities defined as dose-limiting toxicities and maximum tolerated dose.
First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years)
Best Overall Response Rate (Phase 2)
Confirmed best overall response (PR or CR) based on investigator assessment of objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
From first dose of study drug until disease progression (up to approximately 2 years)
Secondary Outcomes (12)
Acute and long-term safety and tolerability of the combination (Phase 2)
From first dose of study drug until disease progression (up to approximately 2 years)
Further evaluation of preliminary efficacy of combination (Phase 2)
From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years)
Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]
From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)
Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]
From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)
Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]
From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)
- +7 more secondary outcomes
Study Arms (6)
Phase 1b: Dose Escalation
EXPERIMENTAL\- Up to 50 patients with advanced solid tumor
Phase 1b: Food Effect Cohort
EXPERIMENTAL\- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
Phase 2: Expansion Cohort - Endometrial Cancer
EXPERIMENTAL* 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
Phase 2: Expansion Cohort - Ovarian Cancer
EXPERIMENTAL* 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
Phase 2: Expansion Cohort - Clear Cell Cancer
EXPERIMENTAL* Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin * At least 1 prior platinum- and taxane-based chemotherapy regimen
Phase 2: Expansion Cohort - Cervical Cancer
EXPERIMENTAL* 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
Interventions
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
IV nivolumab 480 mg will be administered once every 4 weeks.
Eligibility Criteria
You may qualify if:
- ≥ 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clovis Oncology, Inc.lead
- Bristol-Myers Squibbcollaborator
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
Study Sites (27)
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
Córdoba, Andalusia, 14004, Spain
University Hospital Vall d'Hebron
Barcelona, 08035, Spain
Navarra University Clinic
Madrid, 28027, Spain
La Paz University Hospital
Madrid, 28046, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erika Hamilton, MD
Tennessee Oncology
- PRINCIPAL INVESTIGATOR
Nicole Concin, MD
KEM Kliniken Essen Mitte Evang. Huyssens-Stiftung
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2019
First Posted
August 1, 2019
Study Start
July 29, 2019
Primary Completion
July 1, 2023
Study Completion
January 1, 2024
Last Updated
December 20, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
- Access Criteria
- Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations. Data will be provided by Clovis Oncology.