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An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors

NCT03661632

Description:

The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors
  • Official Title: Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA044-001
  • SECONDARY ID: 2018-002108-15
  • NCT ID: NCT03661632

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
BMS-986310Dose Escalation
NivolumabOpdivo, BMS-936558Dose Escalation

Purpose

The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalPart 1: BMS-986310 + Nivolumab Combination Dose Escalation Sub-Study A: A cohort of Triple-Negative Breast Cancer patients will be administered BMS-986310 as Monotherapy Sub-Study B: A cohort of PD[L]1 Refractory Tumor cancer patients will be randomized 1:1 to receive either monotherapy BMS-986310 or BMS-986310 + Nivolumab
  • BMS-986310
Cohort ExpansionExperimentalPart 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1. BMS-986310 + Nivolumab combination will be administered in specific patient populations.
  • BMS-986310

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with measurable disease per RECIST v1.1 and have at least one lesion
             accessible for biopsy.

          -  ECOG performance status less than or equal to 1

        Part 1 and Sub-study B:

        i) Part 1 participants must have advanced or metastatic disease where no other standard of
        care treatment option is possible.

        ii) Sub-study B participants must have advanced or metastatic disease where no other
        standard of care treatment is possible, and they must have had disease progression on an
        anti-PD-(L)1 based regimen as their most recent prior therapy

        Sub-study A:

        i) Males and females with histologically confirmed TNBC as defined by ASCO/CAP guidelines.

        ii) Participants must be newly diagnosed, no prior history of treatment for TNBC.

        iii) Tumor size greater than or equal to 1cm3 iv) Participants must not meet criteria for
        standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of
        primary tumor.

        Part 2 i) Patients with NSCLC ii) Patients with Pancreatic Cancer iii) Patients with TNBC
        iiii) Patients with CRC

        Exclusion Criteria:

          -  History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs
             (NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed

          -  Participants with an active, known or suspected autoimmune disease.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Adverse Events (AE)
Time Frame:up to 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Median duration of response (mDOR)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Progression free survival rate (PFSR)
Time Frame:up to 24 months
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Observed serum concentration at the end of a dosing interval (Ctau)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Apparent total body clearance (CLT/F)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:AUC accumulation index (AI_AUC)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Cmax accumulation index (AI_Cmax)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Summary changes of prostaglandin E metabolite (PGEM) in urine
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Summary changes of tumor necrosis factor (TNFa) in blood
Time Frame:up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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