Clinical Trials /

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:
  • Bladder Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma
  • Renal Cell Carcinoma
Recruiting Status:

Completed

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-986310Cohort Expansion
NivolumabOpdivo, BMS-936558Cohort Expansion

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 Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy. Sub-Study B: A cohort of PD[L]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab
  • BMS-986310
  • Nivolumab
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
  • Nivolumab

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, in one of the following tumor types: Renal cell
        carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High
        (determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing
        methodology must be provided), Bladder cancer, Squamous Cell Carcinoma of the Head and Neck
        (SCCHN), 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) Participants must be newly diagnosed, no prior history of treatment for bladder cancer
        ii) Participants must not meet criteria for standard of care neoadjuvant therapy and must
        be candidates for SOC surgical resection of primary tumor.

        iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure or mixed histology
        urothelial carcinoma Part 2 - Patients with relapsed / refractory solid tumors where no
        other standard of care treatment option is available.

        Exclusion Criteria:

          -  History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs
             (NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors.

          -  Participants with an active, known or suspected autoimmune disease.

          -  Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECG or clinical laboratory determinations beyond
             what is consistent with the target population
      
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:
Measure:Summary of PK parameters at T-HALF
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Summary of PK parameter AUC(INF) after single dose
Time Frame:up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Bristol-Myers Squibb

Last Updated

March 17, 2021