An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Malignant Solid Tumor

Treatments

Biological: Nivolumab
Biological: BMS-986179
Biological: rHuPH20

Study type

Interventional

Funder types

Industry

Identifiers

NCT02754141
2016-000603-91 (EudraCT Number)
CA013-004

Details and patient eligibility

About

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Enrollment

235 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable lab testing results
  • Allow biopsies

Exclusion Criteria:

  • Central nervous system (CNS) tumors
  • Uncontrolled or significant cardiovascular diseases
  • Active or known autoimmune disease
  • Organ transplant

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

235 participants in 3 patient groups

Arm A-Monotherapy
Experimental group
Description:
BMS-986179, dose as specified
Treatment:
Biological: BMS-986179
Arm B- Combination Therapy
Experimental group
Description:
BMS-986179 + nivolumab, dose as specified
Treatment:
Biological: BMS-986179
Biological: Nivolumab
Arm C-Combination Therapy
Experimental group
Description:
BMS-986179 + rHuPH20, dose as specified
Treatment:
Biological: rHuPH20
Biological: BMS-986179

Trial documents
1

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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