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

NCT04042116

Description:

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)

Related Conditions:
  • Malignant Female Reproductive System Neoplasm
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CO-3810-101
  • NCT ID: NCT04042116

Conditions

  • Advanced Solid Tumor
  • Gynecologic Cancer

Interventions

DrugSynonymsArms
LucitanibCO-3810Lucitanib + Nivolumab
NivolumabOpdivo, BMS-936558-0Lucitanib + Nivolumab

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Lucitanib + NivolumabExperimentalPhase 1b (Dose escalation): Up to 50 patients with advanced solid tumor. Phase 2 (Dose expansion): Up to 182 patients with advanced gynecological malignancies.
  • Lucitanib
  • Nivolumab

Eligibility 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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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)
Safety Issue:
Description:Incidence of adverse events and clinical lab abnormalities defined as dose-limiting toxicities and maximum tolerated dose.

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:Incidence of AEs, clinical lab abnormalities, and dose modifications.
Measure: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)
Safety Issue:
Description:Per RECIST v1.1: Duration of response, disease control, progression-free survival, overall survival.
Measure: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)
Safety Issue:
Description:Lucitanib PK
Measure:Steady state minimum plasma concentration [Cmin]
Time Frame:From first dose of study drug until the end of study (up to approximately 2 years)
Safety Issue:
Description:Lucitanib PK
Measure:Steady state maximum plasma concentration [Cmax]
Time Frame:From first dose of study drug until the end of study (up to approximately 2 years)
Safety Issue:
Description:Lucitanib PK
Measure: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)
Safety Issue:
Description:Lucitanib PK

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Clovis Oncology, Inc.

Trial Keywords

  • lucitanib
  • nivolumab
  • antineoplastic agents immunological
  • antineoplastic agents
  • tyrosine kinase inhibitors
  • gynecologic neoplasms
  • checkpoint inhibitor

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