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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Advanced Cancer

Treatments

Biological: BMS-986249
Biological: Nivolumab
Biological: Ipilimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03369223
CA030-001
2018-000416-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

425 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

425 participants in 11 patient groups

Part 1A: BMS-986249
Experimental group
Treatment:
Biological: BMS-986249
Part 1B: BMS-986249 + nivolumab (nivo)
Experimental group
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2A Arm C: BMS-986249 + nivo
Experimental group
Description:
Previously untreated unresectable stage III-IV melanoma
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2A Arm D: ipilimumab + nivo then nivo
Experimental group
Description:
Previously untreated unresectable stage III-IV melanoma
Treatment:
Biological: Ipilimumab
Biological: Nivolumab
Part 2A Arm F: BMS-986249 + nivo
Experimental group
Description:
Previously untreated unresectable stage III-IV melanoma
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2B Cohort 1: BMS-986249 + nivo
Experimental group
Description:
Advanced or intermediate hepatocellular carcinoma (HCC)
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2B Cohort 2: BMS-986249 + nivo
Experimental group
Description:
Metastatic castration-resistant prostate cancer (CRPC)
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2B Cohort 3: BMS-986249 + nivo
Experimental group
Description:
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2A Arm A: BMS-986249 + nivo then nivo
Experimental group
Description:
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2A Arm B: BMS-986249 + nivo
Experimental group
Description:
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Treatment:
Biological: Nivolumab
Biological: BMS-986249
Part 2A Arm E: Nivo
Experimental group
Description:
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Treatment:
Biological: Nivolumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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