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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 Patients With Solid Cancers That Are Advanced or Have Spread

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02737475
First received: April 8, 2016
Last updated: July 18, 2017
Last verified: July 2017
  Purpose
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 patients with solid cancers that are advanced or have spread.

Condition Intervention Phase
Advanced Cancer Drug: BMS-986178 Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study of BMS-986178 Administered Alone and in Combination With Nivolumab and/or Ipilimumab in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence of AE's (adverse events) and SAE's (serious adverse events), AE's leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: Approximately 4 years. ]

Secondary Outcome Measures:
  • Cmax (maximum observed serum concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • Tmax (time of maximum observed concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • Ctau (the observed concentration at the end of a dosing interval) for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • CLT (total body clearance) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • Ctrough [trough observed plasma concentrations (this includes pre-dose concentrations (C0) and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • Immunoassay of anti-nivolumab antibody in combination with anti-BMS- 986178 antibody [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody [ Time Frame: Approximately 100 days after the final study drug administration (end of treatment) ]
  • Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
  • Progression Free Survival Rate (PFSR) [ Time Frame: Approximately 2 years ]
  • Immunoassay of anti-BMS-986178 antibody alone [ Time Frame: Approximately 100 days after 6 months of treatment ]

Estimated Enrollment: 435
Actual Study Start Date: June 16, 2016
Estimated Study Completion Date: May 20, 2020
Estimated Primary Completion Date: February 24, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Dose Escalation
BMS-986178 at specified doses at specified intervals
Drug: BMS-986178
Specified dose on specified days
Experimental: Part 2: Dose Escalation and Expansion
BMS-986178 in combination with Nivolumab at specified doses at specified intervals
Drug: BMS-986178
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Part 3: Dose Escalation and Expansion
BMS-986178 in combination with Ipilimumab at specified doses at specified intervals
Drug: BMS-986178
Specified dose on specified days
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 4: Dose Schedule and Exploration
BMS-986178/Nivolumab at specified doses at specified intervals
Drug: BMS-986178
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Part 5: Dose Schedule and Exploration
BMS-986178/Ipilimumab at specified doses at specified intervals
Drug: BMS-986178
Specified dose on specified days
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 6: Dose Safety and Expansion
BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals
Drug: BMS-986178
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 7: Dose Safety and Expansion
BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals
Drug: BMS-986178
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Other protocol defined inclusion/exclusion criteria could apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02737475

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Stephen Leong, Site 0023    303-724-3837      
United States, District of Columbia
Local Institution Not yet recruiting
Washington, D.C., District of Columbia, United States, 20007
Contact: Site 0018         
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0007    551-996-5900      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Igor Puzanov, Site 0019         
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Richard Carvajal, Site 0002    646-317-3141      
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Site 0017         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Anthony Olszanski, Site 0006    215-214-1676      
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0004         
Canada, Ontario
Local Institution Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 0005         
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Site 0003         
France
Local Institution Not yet recruiting
Toulouse, France, 31100
Contact: Site 0016         
Local Institution Not yet recruiting
Villejuif, France, 94800
Contact: Site 0015         
Italy
Local Institution Recruiting
Milano, Italy, 20133
Contact: Site 0020         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 0008         
Universitair Medisch Centrum Utrecht Active, not recruiting
Utrecht, Netherlands, 3508GA
Spain
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0010         
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28049
Contact: Victor Moreno Garcia, Site 0012         
Local Institution Recruiting
Majadahonda - Madrid, Spain, 28222
Contact: Site 0014         
Hospital Universitario Virgen De La Victoria Recruiting
Malaga, Spain, 29010
Contact: Jose Manuel Trigo Perez, Site 0013         
Local Institution Recruiting
Pamplona, Spain, 31008
Contact: Site 0009         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02737475     History of Changes
Other Study ID Numbers: CA012-004
2015-004816-39 ( EudraCT Number )
Study First Received: April 8, 2016
Last Updated: July 18, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017