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Trial record 1 of 2 for:    lucitanib and nivolumab
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A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

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ClinicalTrials.gov Identifier: NCT04042116
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
Bristol-Myers Squibb
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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)

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Gynecologic Cancer Drug: Lucitanib Drug: Nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Experimental: Phase 1b: Dose Escalation
- Up to 50 patients with advanced solid tumor
Drug: Lucitanib
Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
Other Name: CO-3810

Drug: Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Phase 1b: Food Effect Cohort
- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
Drug: Lucitanib
Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.
Other Name: CO-3810

Drug: Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Other Names:
  • Opdivo
  • BMS-936558

Experimental: 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
Drug: 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.

Other Name: CO-3810

Drug: Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Other Names:
  • Opdivo
  • BMS-936558

Experimental: 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
Drug: 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.

Other Name: CO-3810

Drug: Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Other Names:
  • Opdivo
  • BMS-936558

Experimental: 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
Drug: 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.

Other Name: CO-3810

Drug: Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Other Names:
  • Opdivo
  • BMS-936558

Experimental: 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
Drug: 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.

Other Name: CO-3810

Drug: Nivolumab
IV nivolumab 480 mg will be administered once every 4 weeks.
Other Names:
  • Opdivo
  • BMS-936558




Primary Outcome Measures :
  1. 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) ]
    Incidence of adverse events and clinical lab abnormalities defined as dose-limiting toxicities and maximum tolerated dose.

  2. Best Overall Response Rate (Phase 2) [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    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.


Secondary Outcome Measures :
  1. Acute and long-term safety and tolerability of the combination (Phase 2) [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Incidence of AEs, clinical lab abnormalities, and dose modifications.

  2. Further evaluation of preliminary efficacy of combination (Phase 2) [ Time Frame: From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years) ]
    Duration of response, progression-free survival, and disease control per RECIST v1.1, overall survival.

  3. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] [ Time Frame: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days) ]
    Area under the curve [AUCss]

  4. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] [ Time Frame: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days) ]
    Maximum plasma concentration [Cmax,ss]

  5. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] [ Time Frame: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days) ]
    Total clearance of drug after oral administration [CLss/F]

  6. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect, Phase 2] [ Time Frame: From Cycle 2 to Cycle 5 (each cycle is 28 days) ]
    Minimum plasma concentration [Cmin,ss]

  7. Lucitanib PK Profile at single dose [Food Effect Cohort] [ Time Frame: From first dose of study drug to Day -1 ]
    Area under the curve [AUC]

  8. Lucitanib PK Profile at single dose [Food Effect Cohort] [ Time Frame: From first dose of study drug to Day -1 ]
    Maximum plasma concentration [Cmax]

  9. Lucitanib PK Profile at single dose [Food Effect Cohort] [ Time Frame: From first dose of study drug to Day -1 ]
    Time to maximum plasma concentration [Tmax]

  10. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] [ Time Frame: From first dose of study drug to Day -1 ]
    Area under the curve [AUC]

  11. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] [ Time Frame: From first dose of study drug to Day -1 ]
    Maximum plasma concentration [Cmax]

  12. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] [ Time Frame: From first dose of study drug to Day -1 ]
    Time to maximum plasma concentration [Tmax]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042116


Contacts
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Contact: Clovis Oncology For North America, Latin America and Asia Pacific inquiries: 1-415-409-7220, 1-844-258-7662 medinfo@clovisoncology.com
Contact: Clovis Oncology For Europe and Rest of World related inquiries: +353 16950030 (toll-paid) MedInfo.IE@clovisoncology.com

Locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
San Diego, California, United States, 92093
United States, Colorado
Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
NYU Langone Laura and Isaac Perlmutter Cancer Center Recruiting
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98107
Austria
Medical University of Innsbruck Recruiting
Innsbruck, Austria, 6020
Belgium
University Hospitals Leuven, Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Spain
University Hospital Reina Sofia Recruiting
Cordoba, Andalusia, Spain, 14004
Sponsors and Collaborators
Clovis Oncology, Inc.
Bristol-Myers Squibb
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
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Principal Investigator: Erika Hamilton, MD Tennessee Oncology, PLLC
Principal Investigator: Nicole Concin, MD KEM Kliniken Essen Mitte Evang. Huyssens-Stiftung
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04042116    
Other Study ID Numbers: CO-3810-101
ENGOT-GYN3/AGO/LIO ( Other Identifier: ENGOT )
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clovis Oncology, Inc.:
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
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents