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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

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ClinicalTrials.gov Identifier: NCT03444753
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 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
Estimated Primary Completion Date : October 4, 2022
Estimated Study Completion Date : October 9, 2023

Resource links provided by the National Library of Medicine


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




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 ]


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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:

  • 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 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): NCT03444753


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, California
University Of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093-0698
Contact: Sandip Patel, Site 0003    858-822-1962      
Local Institution Not yet recruiting
Orange, California, United States, 92868
Contact: Site 0008         
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Karen Kelly, Site 0007    916-734-3604      
United States, Connecticut
Local Institution Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Site 0005         
United States, Michigan
Local Institution Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Site 0010         
United States, Missouri
Washington University Completed
Saint Louis, Missouri, United States, 63110
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Site 0009         
United States, Pennsylvania
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232-1305
Contact: Site 0006         
United States, Texas
MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
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: NCT03444753    
Other Study ID Numbers: CA039-001
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

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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