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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

166

Study ID:

NCT02737475

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 22 Locations for this study

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University Of Colorado
Aurora Colorado, 80045, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Columbia University Medical Center (Cumc)
New York New York, 10032, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Local Institution
Ottawa Ontario, K1H 8, Canada
Local Institution
Toronto Ontario, M5G 1, Canada
Local Institution
Ramat Gan , 52621, Israel
Local Institution
Tel Aviv , 64239, Israel
IRCCS Istituto Nazionale Tumori Milano
Milano , 20133, Italy
Istituto Clinico Humanitas
Rozzano , 20089, Italy
Local Institution
Amsterdam , 1066 , Netherlands
Local Institution
Utrecht , 3584 , Netherlands
H. Univ. Vall dHebron
Barcelona , 08035, Spain
Fundacion Jimenez Diaz
Madrid , 28049, Spain
Hosp. Univ. Puerta De Hierro
Majadahonda - Madrid , 28222, Spain
Hospital Universitario Virgen De La Victoria
Malaga , 29010, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

166

Study ID:

NCT02737475

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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