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An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

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ClinicalTrials.gov Identifier: NCT03956680
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab to participants with cancers that have failed to respond to or are known to be insensitive to T cell checkpoint inhibiting antibodies.

Condition or disease Intervention/treatment Phase
Advanced Solid Cancers Drug: BMS-986301 Drug: Nivolumab Drug: Ipilimumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : August 18, 2022
Estimated Study Completion Date : March 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMS-986301 followed by Nivolumab and Ipilimumab therapy Drug: BMS-986301
Participants will receive dose 1 on Day 1 and Day 22 of cycle 1.

Drug: Nivolumab
Participants will receive Dose 2 on Day 1 of cycle 2.

Drug: Ipilimumab
Participants will receive Dose 3 on Day 1 of cycle 2.




Primary Outcome Measures :
  1. Number of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]
  2. Number of Participants With Adverse Events (AEs), Serious AEs, AEs leading to Discontinuation and Deaths [ Time Frame: From Baseline until study exit (up to approximately 2 years) ]
  3. Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: From Baseline until disease progression (approximately 2 years) ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986301 [ Time Frame: approximately 2 years ]
  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-986301 [ Time Frame: approximately 2 years ]
  3. Area under the concentration-time curve in one dosing interval (24 h) of BMS-986301 [ Time Frame: Up to 24 hours ]
  4. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of BMS-986301 [ Time Frame: approximately 2 years ]
  5. Changes in Levels and Activation of Tumor Infiltrating T Cells [ Time Frame: approximately 2 years ]
  6. Change in Programmed Death-Ligand 1 (PD-L1) Expression Status in Tumors [ Time Frame: approximately 2 years ]
  7. BMS-986301-induced Changes in Cytokines in Blood and Tumors [ 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 1 (intramuscular treatment group) or 2 (intratumoral treatment group) 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): NCT03956680


Contacts
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Contact: Recruiting sites have contact information. 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, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Site 0003         
United States, Maryland
Local Institution Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Site 0004         
United States, Missouri
Local Institution Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site 0005         
United States, Pennsylvania
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site 0006         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Filip Janku, Site 0002    713-745-4297      
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03956680     History of Changes
Other Study ID Numbers: CA046-006
2018-003610-41 ( EudraCT Number )
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 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