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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 : January 31, 2019
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 Biological: BMS-986299 Biological: Nivolumab Biological: Ipilimumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : March 20, 2018
Estimated Primary Completion Date : November 14, 2021
Estimated Study Completion Date : December 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
BMS-986299
Biological: BMS-986299
Specified dose on specified day

Experimental: Arm B
BMS-986299 in combination with nivolumab and ipilimumab
Biological: 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 serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
  4. Incidence of AEs leading to discontinuation and deaths [ Time Frame: Approximately 2 years ]
  5. Incidence of clinical laboratory abnormalities [ 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 central nervous system 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         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Andrea Wang-Gillam, Site 0002         
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 10065
Contact: Site 0004         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Filip Janku, Site 0001         
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     History of Changes
Other Study ID Numbers: CA039-001
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 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