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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA030-001  |   NCT03369223

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Key Eligibility Criteria

Inclusion Criteria: - Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed. - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists - Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants - Willing and able to comply with all study procedures Exclusion Criteria: - Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded - Other active malignancy requiring concurrent intervention - Prior organ allograft - Active, known, or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1A: BMS-986249

ASSIGNED INTERVENTION
  • Biological: BMS-986249

Study Arms

Experimental: Part 1B: BMS-986249 + nivolumab (nivo)

ASSIGNED INTERVENTION
  • Biological: Nivolumab, BMS-986249

Study Arms

Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo

ASSIGNED INTERVENTION
  • Biological: Nivolumab, BMS-986249

Study Arms

Experimental: Part 2A Arm B: BMS-986249 + nivo

ASSIGNED INTERVENTION
  • Biological: Nivolumab, BMS-986249

Study Arms

Experimental: Part 2A Arm C: BMS-986249 + nivo

ASSIGNED INTERVENTION
  • Biological: Nivolumab, BMS-986249

Study Arms

Experimental: Part 2A Arm D: ipilimumab + nivo then nivo

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Ipilimumab

Study Arms

Experimental: Part 2A Arm E: Nivo

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: Part 2A Arm F: BMS-986249 + nivo

ASSIGNED INTERVENTION
  • Biological: Nivolumab, BMS-986249

Study Arms

Experimental: Part 2B Cohort 1: BMS-986249 + nivo

ASSIGNED INTERVENTION
  • Biological: BMS-986249, Nivolumab

Study Arms

Experimental: Part 2B Cohort 2: BMS-986249 + nivo

ASSIGNED INTERVENTION
  • Biological: BMS-986249, Nivolumab

Study Arms

Experimental: Part 2B Cohort 3: BMS-986249 + nivo

ASSIGNED INTERVENTION
  • Biological: BMS-986249, Nivolumab

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