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A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05298592
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone and in combination with nivolumab in participants with advanced tumors.

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: BMS-986406 Biological: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors
Actual Study Start Date : March 31, 2022
Estimated Primary Completion Date : April 9, 2026
Estimated Study Completion Date : July 8, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Part 1A: BMS-986406 (Monotherapy Dose Escalation) Biological: BMS-986406
Specified dose on specified days

Experimental: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation) Biological: BMS-986406
Specified dose on specified days

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

Experimental: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion) Biological: BMS-986406
Specified dose on specified days

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

Experimental: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) Biological: BMS-986406
Specified dose on specified days

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




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 100 days ]
  2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 100 days ]
  3. Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 28 days ]
  4. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days ]
  5. Number of participants with death [ Time Frame: Up to 100 days ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 14 days ]
  2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 14 days ]
  3. Trough observed plasma concentration (Ctrough) [ Time Frame: Up to 14 days ]
  4. Incidence of anti-drug antibody (ADAs) [ Time Frame: Up to 14 days ]
  5. Objective response rate (ORR) [ Time Frame: Up to 24 months ]
  6. Disease control rate (DCR) [ Time Frame: Up to 24 months ]
  7. Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma [ Time Frame: Up to 24 months ]
  8. DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer [ Time Frame: Up to 24 months ]
  9. DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types [ Time Frame: Up to 24 months ]


Information from the National Library of Medicine

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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 locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
  • Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Prior organ or tissue allograft
  • Leptomeningeal metastases
  • Untreated CNS metastases
  • Serious or uncontrolled medical disorders

Other protocol-defined inclusion/exclusion criteria 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): NCT05298592


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT # and Site #.

Locations
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United States, California
Local Institution Not yet recruiting
Los Angeles, California, United States, 90025
Contact: Site 0004         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0001    551-996-5863      
United States, North Carolina
Carolina Biooncology Institute, Pllc Recruiting
Huntersville, North Carolina, United States, 28078
Contact: John Powderly, Site 0002    704-654-0485      
United States, Pennsylvania
Fox Chase Cancer Center Withdrawn
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Local Institution Not yet recruiting
Dallas, Texas, United States, 75230
Contact: Site 0005         
United States, Virginia
Local Institution Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Site 0006         
Spain
Local Institution Not yet recruiting
Barcelona, Spain, 08916
Contact: Site 0007         
Local Institution Not yet recruiting
Malaga, Spain, 29010
Contact: Site 0008         
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: NCT05298592    
Other Study ID Numbers: CA111-001
2021-006872-17 ( EudraCT Number )
U1111-1270-3670 ( Registry Identifier: WHO )
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Opdivo®
Immunotherapy
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action