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An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444753
Recruitment Status : Terminated (business objectives have changed)
First Posted : February 23, 2018
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: BMS-986299 Biological: Nivolumab Biological: Ipilimumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : February 14, 2022
Actual Study Completion Date : February 14, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
BMS-986299
 Drug: BMS-986299
Specified dose on specified day
Experimental: Arm B
BMS-986299 in combination with nivolumab and ipilimumab
 Drug: BMS-986299
Specified dose on specified day

Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified day
Other Names:
  • Yervoy
  • BMS-734016


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
  2. Incidence of adverse events (AEs) [ Time Frame: Approximately 2 years ]
  3. Incidence of clinical laboratory abnormalities [ Time Frame: Approximately 2 years ]
  4. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
  5. Incidence of AEs leading to discontinuation and deaths [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 2 years ]
  2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 2 years ]
  3. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
  4. Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)] [ Time Frame: Approximately 2 years ]

Eligibility Criteria
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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

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
  • IO therapy resistant or insensitive tumors
  • Have at least 2 tumor lesions accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Primary CNS malignancy
  • Participants with other active malignancy requiring concurrent intervention
  • Uncontrolled or significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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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): NCT03444753


Locations
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United States, California
Local Institution - 0003
La Jolla, California, United States, 92093-0698
Local Institution
Orange, California, United States, 92868
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Connecticut
Local Institution
New Haven, Connecticut, United States, 06520
United States, Michigan
Local Institution
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Oregon
Local Institution
Portland, Oregon, United States, 97239
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03444753    
Other Study ID Numbers: CA039-001
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action