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An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment

NCT03335540

Description:

The purpose of this study is to evaluate the treatment of solid tumors with various immunotherapy combinations. The treatment will be determined based upon a broad biomarker assessment.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment
  • Official Title: ADaptiVe Biomarker Trial That InformS Evolution of Therapy

Clinical Trial IDs

  • ORG STUDY ID: CA028-001
  • NCT ID: NCT03335540

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558Arm B
RelatlimabBMS-986016Arm B
CabiralizumabBMS-986227, FPA008Arm C
IpilimumabBMS-734016Arm D
IDO1 InhibitorBMS-986205Arm F

Purpose

The purpose of this study is to evaluate the treatment of solid tumors with various immunotherapy combinations. The treatment will be determined based upon a broad biomarker assessment.

Trial Arms

NameTypeDescriptionInterventions
Arm BExperimentalCombination therapy determined by biomarker assessment
  • Nivolumab
  • Relatlimab
Arm CExperimentalCombination therapy determined by biomarker assessment
  • Nivolumab
  • Cabiralizumab
Arm DExperimentalCombination therapy determined by biomarker assessment
  • Nivolumab
  • Ipilimumab
Arm FExperimentalCombination therapy determined by biomarker assessment
  • Nivolumab
  • IDO1 Inhibitor
Arm GExperimentalCombination therapy determined by biomarker assessment
  • Nivolumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants must have an ECOG performance status of less than or equal to 1

          -  Participants must have had prior therapy;Participants who have received adjuvant or
             neoadjuvant anti-PD(L)1 therapy andprogressed within 6 months of completing therapy
             will be considered IO refractory.

          -  Participants must have at least 2 lesions with measurable disease as defined by RECIST
             Version 1.1

        Exclusion Criteria:

          -  Participants with suspected, known, or progressive CNS metastases, have untreated CNS
             metastases, or have the CNS as the only site of disease

          -  Participants with carcinomatous meningitis

          -  Participants with other active malignancy requiring concurrent intervention

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with qualified tumor biopsy specimen at baseline
Time Frame:Up to 28 days
Safety Issue:
Description:An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT)

Secondary Outcome Measures

Measure:Percent of change from baseline in histopathologic features
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Percent of change from baseline in biomarker expression patterns
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Number of Adverse Events (AEs)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Number of Serious Adverse Events (SAEs)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Number of Laboratory Abnormalities
Time Frame:Up to 4 years
Safety Issue:
Description:Any laboratory test result that is clinically significant or meets the definition of an SAE, requires the participant to have study treatment discontinued, or receive specific corrective therapy
Measure:Number of Adverse Events(AEs) leadind to discontinutaion
Time Frame:up to 4 years
Safety Issue:
Description:Number of Adverse Events leadind to discontinutaion
Measure:Number of Deaths
Time Frame:up to 4 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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