Breast Cancer Clinical Trial
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
Summary
The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in participants with solid cancers that are advanced or have spread.
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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There are 22 Locations for this study
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
New York New York, 10032, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19111, United States
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Milano , 20133, Italy
Rozzano , 20089, Italy
Amsterdam , 1066 , Netherlands
Utrecht , 3584 , Netherlands
Barcelona , 08035, Spain
Madrid , 28049, Spain
Majadahonda - Madrid , 28222, Spain
Malaga , 29010, Spain
Pamplona , 31008, Spain
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