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Advanced Solid TumorPhase 1/2NCT04042116

A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

A Phase 1/2 study testing Lucitanib and Nivolumab in people with Advanced Solid Tumor and Gynecologic Cancer, run by Clovis Oncology, Inc. at 27 sites in 6 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Gynecologic Cancer
What is being tested?
Lucitanib and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
27 sitesin 6 countries
Study dates
29 Jul 2019to Jan 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

27 sites in 6 countries.

27 sites in 6 countries

United States13 sites

  • Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Duke University School of Medicine

    Durham, North Carolina, 27710

  • UCLA Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • NYU Langone Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • UC San Diego Moores Cancer Center

    San Diego, California, 92093

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Swedish Cancer Institute

    Seattle, Washington, 98107

Other trials in United States

Spain4 sites

  • University Hospital Vall d'Hebron

    Barcelona, 08035

  • University Hospital Reina Sofia

    Córdoba, Andalusia, 14004

  • Navarra University Clinic

    Madrid, 28027

  • La Paz University Hospital

    Madrid, 28046

Other trials in Spain

Belgium3 sites

  • Saint Luc Univerisity Hospital

    Brussels, 1200

  • University Hospital Ghent

    Ghent, 9000

  • University Hospitals Leuven, Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Germany3 sites

  • University Hospital Carl Gustav Carus

    Dresden, 01307

  • Kliniken Essen-Mitte

    Essen, 45136

  • University Hospital Mannhein

    Mannheim, 68167

Other trials in Germany

Italy3 sites

  • Polyclinic S. Orsola-Malpighi

    Bologna, 40138

  • National Cancer Institute -IRCCS "Fondazione G. Pascale

    Naples, 80131

  • Foundation IRCCS Hospital Agostino Gemelli

    Rome, 00168

Other trials in Italy

Austria1 site

  • Medical University of Innsbruck

    Innsbruck, 6020

Other trials in Austria

About this study

Official title: 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

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)

Being tested
Lucitanib, Nivolumab
Keywords
lucitanib, nivolumab, antineoplastic agents immunological, antineoplastic agents, tyrosine kinase inhibitors, gynecologic neoplasms, checkpoint inhibitor, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, clear cell cancer, cervical cancer, PD-1 inhibitor, Immuno-oncology
Medical subject headings
Genital Neoplasms, Female, Ovarian Neoplasms, Fallopian Tube Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LucitanibDrug

    Also called CO-3810

    Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.

  • LucitanibDrug

    Also called CO-3810

    Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.

  • LucitanibDrug

    Also called CO-3810

    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.

  • NivolumabDrug

    Also called Opdivo, BMS-936558

    IV nivolumab 480 mg will be administered once every 4 weeks.

Study groups in NCT04042116
Study groupRoleWhat they receive
Phase 1b: Dose EscalationExperimental- Up to 50 patients with advanced solid tumor
Receives: Drug: Lucitanib; Drug: Nivolumab
Phase 1b: Food Effect CohortExperimental- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
Receives: Drug: Lucitanib; Drug: Nivolumab
Phase 2: Expansion Cohort - Endometrial CancerExperimental* 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
Receives: Drug: Lucitanib; Drug: Nivolumab
Phase 2: Expansion Cohort - Ovarian CancerExperimental* 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
Receives: Drug: Lucitanib; Drug: Nivolumab
Phase 2: Expansion Cohort - Clear Cell CancerExperimental* Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin * At least 1 prior platinum- and taxane-based chemotherapy regimen
Receives: Drug: Lucitanib; Drug: Nivolumab
Phase 2: Expansion Cohort - Cervical CancerExperimental* 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
Receives: Drug: Lucitanib; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years)

  2. 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.

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

Secondary outcomes (12)

  1. Acute and long-term safety and tolerability of the combination (Phase 2)

    Incidence of AEs, clinical lab abnormalities, and dose modifications.

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

  2. Further evaluation of preliminary efficacy of combination (Phase 2)

    Duration of response, progression-free survival, and disease control per RECIST v1.1, overall survival.

    Measured: From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years)

  3. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]

    Area under the curve [AUCss]

    Measured: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)

  4. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]

    Maximum plasma concentration [Cmax,ss]

    Measured: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)

  5. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]

    Total clearance of drug after oral administration [CLss/F]

    Measured: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)

  6. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect, Phase 2]

    Minimum plasma concentration [Cmin,ss]

    Measured: From Cycle 2 to Cycle 5 (each cycle is 28 days)

  7. Lucitanib PK Profile at single dose [Food Effect Cohort]

    Area under the curve [AUC]

    Measured: From first dose of study drug to Day -1

  8. Lucitanib PK Profile at single dose [Food Effect Cohort]

    Maximum plasma concentration [Cmax]

    Measured: From first dose of study drug to Day -1

  9. Lucitanib PK Profile at single dose [Food Effect Cohort]

    Time to maximum plasma concentration [Tmax]

    Measured: From first dose of study drug to Day -1

  10. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort]

    Area under the curve [AUC]

    Measured: From first dose of study drug to Day -1

  11. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort]

    Maximum plasma concentration [Cmax]

    Measured: From first dose of study drug to Day -1

  12. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort]

    Time to maximum plasma concentration [Tmax]

    Measured: From first dose of study drug to Day -1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start29 Jul 2019
  3. Primary completionJul 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Why it stopped: Company decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
227 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04042116
Sponsor's protocol ID
CO-3810-101
Other IDs
ENGOT-GYN3/AGO/LIO
Status last verified
Dec 2022
First submitted
19 Jul 2019
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lucitanib and Nivolumab in people with Advanced Solid Tumor and Gynecologic Cancer, run by Clovis Oncology, Inc. at 27 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Spain, Belgium, Germany, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b) (time frame: First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04042116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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