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
NCT ID: NCT02737475
Last Updated: 2022-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
166 participants
INTERVENTIONAL
2016-06-17
2020-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
* BMS-986178 at specified doses at specified intervals
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Part 2: Dose Escalation and Expansion
* BMS-986178 in combination with Nivolumab at specified doses at specified intervals
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 3: Dose Escalation and Expansion
* BMS-986178 in combination with Ipilimumab at specified doses at specified intervals
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 4: Dose Schedule and Exploration
* BMS-986178/Nivolumab at specified doses at specified intervals
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 5: Dose Schedule and Exploration
* BMS-986178/Ipilimumab at specified doses at specified intervals
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 6: Dose Safety and Expansion
* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 7: Dose Safety and Expansion
* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 8: Dose Exploration
* BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval
* Enrollment is closed for this arm
BMS-986178
Specified dose on specified days
Nivolumab
Specified dose on specified days
Tetanus vaccine
Specified dose on specified days
Part 9: Dose Exploration
* BMS-986178/Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 1) at specified doses at specified intervals OR Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 2) at specified doses at specified intervals
* Enrollment is open for this arm \[Tumor type triple negative breast cancer (TNBC)\]
BMS-986178
Specified dose on specified days
Nivolumab
Specified dose on specified days
DPV-001 vaccine
DPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Interventions
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BMS-986178
Specified dose on specified days
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Tetanus vaccine
Specified dose on specified days
DPV-001 vaccine
DPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Colorado
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center (Cumc)
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Ramat Gan, , Israel
Local Institution
Tel Aviv, , Israel
IRCCS Istituto Nazionale Tumori Milano
Milan, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Local Institution
Amsterdam, , Netherlands
Local Institution
Utrecht, , Netherlands
H. Univ. Vall dHebron
Barcelona, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hosp. Univ. Puerta De Hierro
Majadahonda - Madrid, , Spain
Hospital Universitario Virgen De La Victoria
Málaga, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Countries
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References
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Gutierrez M, Moreno V, Heinhuis KM, Olszanski AJ, Spreafico A, Ong M, Chu Q, Carvajal RD, Trigo J, Ochoa de Olza M, Provencio M, De Vos FY, De Braud F, Leong S, Lathers D, Wang R, Ravindran P, Feng Y, Aanur P, Melero I. OX40 Agonist BMS-986178 Alone or in Combination With Nivolumab and/or Ipilimumab in Patients With Advanced Solid Tumors. Clin Cancer Res. 2021 Jan 15;27(2):460-472. doi: 10.1158/1078-0432.CCR-20-1830. Epub 2020 Nov 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2015-004816-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA012-004
Identifier Type: -
Identifier Source: org_study_id
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