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

  • Clinicaltrials.gov identifier

    NCT05298592

  • Recruitment Status

    Recruiting

  • First Posted

    March 28, 2022

  • Last update posted

    June 30, 2022

Study Description

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:Advanced Cancer
  • Intervention/Treatment: Biological: BMS-986406
    Biological: Nivolumab
  • Phase: Phase 1

Detailed Description

N/A

Study Design

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

Arms and interventions

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

Biological: Nivolumab
Specified dose on specified days

Outcome Measures

  • 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 ]

Eligibility Criteria

  • 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

Contacts and Locations

Contacts

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

United States, California
Local Institution
Los Angeles

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, North Carolina
Carolina Biooncology Institute, Pllc
Huntersville

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia

United States, Texas
Local Institution
Dallas

United States, Virginia
Local Institution
Richmond

Spain
Local Institution
Barcelona

Spain
Local Institution
Malaga

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05298592 History of Changes
  • Other Study ID Numbers: CA111-001, 2021-006872-17, U1111-1270-3670
  • First Posted: March 28, 2022 Key Record Dates
  • Last Update Posted: June 30, 2022
  • Last Verified: June 2022
  • 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