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

Overview

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.

Full Title of Study: “Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 11, 2019

Interventions

  • Drug: BMS-986310
    • Specified dose on specified days
  • Biological: Nivolumab
    • Specified dose on specified days

Arms, Groups and Cohorts

  • Experimental: Dose Escalation
    • Part 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
  • Experimental: Cohort Expansion
    • Part 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Adverse Events (AE)
    • Time Frame: up to 3 years
  • Incidence of Serious Adverse Events (SAE)
    • Time Frame: up to 3 years
  • Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
    • Time Frame: up to 3 years
  • Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)
    • Time Frame: up to 3 years
  • Incidence of Laboratory abnormalities
    • Time Frame: up to 3 years
  • Incidence of death
    • Time Frame: up to 3 years

Secondary Measures

  • Objective response rate (ORR)
    • Time Frame: up to 3 years
  • Median duration of response (mDOR)
    • Time Frame: up to 3 years
  • Progression free survival rate (PFSR)
    • Time Frame: up to 24 months
  • Maximum observed serum concentration (Cmax)
    • Time Frame: up to 3 years
  • Observed serum concentration at the end of a dosing interval (Ctau)
    • Time Frame: up to 3 years
  • 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
  • Apparent total body clearance (CLT/F)
    • Time Frame: up to 3 years
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
    • Time Frame: up to 3 years
  • AUC accumulation index (AI_AUC)
    • Time Frame: up to 3 years
  • Cmax accumulation index (AI_Cmax)
    • Time Frame: up to 3 years
  • Summary changes of prostaglandin E metabolite (PGEM) in urine
    • Time Frame: up to 3 years
  • Summary changes of tumor necrosis factor (TNFa) in blood
    • Time Frame: up to 3 years
  • Summary of PK parameters at T-HALF
    • Time Frame: up to 3 years
  • Summary of PK parameter AUC(INF) after single dose
    • Time Frame: up to 3 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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