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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 : August 1, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
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).

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 : 232 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Lucitanib + Nivolumab

Phase 1b (Dose escalation): Up to 50 patients with advanced solid tumor.

Phase 2 (Dose expansion): Up to 182 patients with advanced gynecological malignancies.

Drug: Lucitanib
Oral lucitanib will be administered once daily. The starting dose will be 6mg daily (QD).
Other Name: CO-3810

Drug: Nivolumab
IV nivolumab 480mg will be administered once every 4 weeks.
Other Names:
  • Opdivo
  • BMS-936558-0




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 or 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) ]
    Per RECIST v1.1: Duration of response, disease control, progression-free survival, overall survival.

  3. Area under the curve at steady state [AUC] [ Time Frame: From first dose of study drug until the end of study (up to approximately 2 years) ]
    Lucitanib PK

  4. Steady state minimum plasma concentration [Cmin] [ Time Frame: From first dose of study drug until the end of study (up to approximately 2 years) ]
    Lucitanib PK

  5. Steady state maximum plasma concentration [Cmax] [ Time Frame: From first dose of study drug until the end of study (up to approximately 2 years) ]
    Lucitanib PK

  6. Total clearance of drug after oral administration [CL/F] [ Time Frame: From first dose of study drug until the end of study (up to approximately 2 years) ]
    Lucitanib PK



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
  • 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 provide an additional biopsy after 4 weeks of treatment (Phase 2)

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 (greater than 140/90 mmHg)
  • Prior treatment with a PD-(L)1 inhibitor or 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 Clinical Trial Information 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial Information 1-303-625-5160 (USA) clovistrials@emergingmed.com

Locations
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United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Clovis Oncology, Inc.
Bristol-Myers Squibb
Investigators
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Study Chair: Lindsey Rolfe, MBChB Clovis Oncology, Inc.

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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04042116     History of Changes
Other Study ID Numbers: CO-3810-101
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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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

Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents
Antineoplastic Agents, Immunological