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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).

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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