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

Updated: 6 October, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's 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.

Trial Details

  • Phase 1/Phase 2


  • Gender(s)

  • 18+

    Age Range

  • 3


  • Recruiting

Treatment Options

Study Arms
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: Nivolumab Drug: BMS-986178
Experimental: Part 5: Dose Schedule and Exploration
Drug: BMS-986178 Drug: Ipilimumab
Experimental: Part 6: Dose Safety and Expansion
Drug: BMS-986178 Drug: Ipilimumab Drug: Nivolumab
Experimental: Part 7: Dose Safety and Expansion
Drug: Nivolumab Drug: BMS-986178 Drug: Ipilimumab
Experimental: Part 8: Dose Exploration
Drug: Nivolumab Drug: BMS-986178 Biological: Tetanus vaccine
Experimental: Part 9: Dose Exploration
Drug: Cyclophosphamide Biological: DPV-001 vaccine 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: For Part 9 (only arm open for enrollment): - Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapies in the advanced metastatic setting - Participants with < 12 months from receipt of last curative-intent chemotherapy are allowed; curative chemotherapy will be considered first-line therapy - Prior receipt of chemotherapy in the (neo)adjuvant setting is acceptable, as long as completed greater than 6 months from start of treatment - Tumor biopsy samples (mandatory pre- and on-treatment biopsies) are required for all participants enrolled - Must have histologic or cytologic confirmation of a malignancy that is advanced (metastatic, recurrent, refractory, and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 - Men and women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Must be immunotherapy treatment naïve, including no prior therapy with T cell immune checkpoint blocker (anti-PDL1, anti-PD1). Prior receipt of intralymphatic cytokine therapy (IRX-2) is acceptable (Part 9 only) - Other active malignancy requiring concurrent intervention - Prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-OX40 antibody, anti-CD137, anti- glucocorticoid-induced TNFR-related gene (anti-GITR) antibody, and anti-CD27 - Known or underlying medical or psychiatric condition and/or social reason that, in the opinion of the investigator or Sponsor, could make the administration of study drug hazardous to the participant or could adversely affect the ability of the participant to comply with or tolerate the study Other protocol-defined inclusion/exclusion criteria apply

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