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Recruiting

An Investigational Immuno-therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Patients With Solid Cancers That Are Advanced or Have Spread - CA012-004

Updated: 02 October, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Please note: This trial is not recruiting for all trial arms at this time

The following study arms are currently recruiting:

  • Trial arm 8 for bladder cancer patients

See below for more information on study arms.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 11

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1: Dose Escalation
Drug: BMS-986178
Experimental: Part 2: Dose Escalation and Expansion
Drug: Nivolumab Drug: BMS-986178
Experimental: Part 3: Dose Escalation and Expansion
Drug: BMS-986178 Drug: Ipilimumab
Experimental: Part 4: Dose Schedule and Exploration
Drug: BMS-986178 Drug: Nivolumab
Experimental: Part 5: Dose Schedule and Exploration
Drug: BMS-986178 Drug: Ipilimumab
Experimental: Part 6: Dose Safety and Expansion
Drug: BMS-986178 Drug: Nivolumab Drug: Ipilimumab
Experimental: Part 7: Dose Safety and Expansion
Drug: Nivolumab Drug: BMS-986178 Drug: Ipilimumab
Experimental: Part 8: Dose Schedule and Exploration
Drug: BMS-986178 Drug: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Patients must have at least 1 standard treatment regimen in the advanced, recurrent or metastatic setting - ECOG (Eastern Cooperative Oncology Group) 0-1 - Men and women 18 years old or older - At least one measurable lesion at baseline by CT (computed tomography) or MRI (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid Tumors) v1.1 - All subjects must have a fresh tumor biopsy Exclusion Criteria: - Known central nervous system metastases or central nervous system as the only source of disease - Concomitant malignancies - Active known or suspected autoimmune disease - Uncontrolled or significant cardiovascular disease - Major surgery less than 4 weeks before the start of the study - Patients with known allergies to egg products, neomycin, or tetanus toxoid - Prior adverse reaction to tetanus toxoid-containing vaccines Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us