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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

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ClinicalTrials.gov Identifier: NCT02737475
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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 patients with solid cancers that are advanced or have spread.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: BMS-986178 Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : May 12, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Part 8: Dose Schedule and Exploration
BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval
Drug: BMS-986178
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo




Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
  14. Progression Free Survival Rate (PFSR) [ Time Frame: Approximately 2 years ]
  15. Immunoassay of anti-BMS-986178 antibody alone [ Time Frame: Approximately 100 days after 6 months of treatment ]
  16. Number of participants showing a change in one of the pharmacodynamic biomarkers of BMS-986178 administered in combination with nivolumab [ Time Frame: Approximately 18 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • Patients with known allergies to egg products, neomycin, or tetanus toxoid
  • Prior adverse reaction to tetanus toxoid-containing vaccines

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737475


Contacts
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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
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United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0023         
United States, District of Columbia
Georgetown University Medical Center Completed
Washington, District of Columbia, United States, 20007
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Active, not recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute Completed
Buffalo, New York, United States, 14263
Columbia University Medical Center (Cumc) Active, not recruiting
New York, New York, United States, 10032
United States, Oregon
Providence Portland Medical Center Active, not recruiting
Portland, Oregon, United States, 97213
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase Cancer Center Completed
Philadelphia, Pennsylvania, United States, 19111
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Quincy Chu, Site 0004    7809898157      
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 Withdrawn
Toulouse, France, 31100
Local Institution Withdrawn
Villejuif, France, 94800
Israel
Local Institution Recruiting
Ramat Gan, Israel, 52621
Contact: Site 0025         
Local Institution Terminated
Tel Aviv, Israel, 64239
Italy
IRCCS Istituto Nazionale Tumori Milano Completed
Milano, Italy, 20133
Istituto Clinico Humanitas Completed
Rozzano, Italy, 20089
Netherlands
Local Institution Active, not recruiting
Amsterdam, Netherlands, 1066 CX
Local Institution Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Site 0011         
Spain
H. Univ. Vall dHebron Completed
Barcelona, Spain, 08035
Fundacion Jimenez Diaz Active, not recruiting
Madrid, Spain, 28049
Hosp. Univ. Puerta De Hierro Completed
Majadahonda - Madrid, Spain, 28222
Hospital Universitario Virgen De La Victoria Active, not recruiting
Malaga, Spain, 29010
Clinica Universidad de Navarra Completed
Pamplona, Spain, 31008
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02737475     History of Changes
Other Study ID Numbers: CA012-004
2015-004816-39 ( EudraCT Number )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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

Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents