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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

  • Clinicaltrials.gov identifier

    NCT03369223

  • Recruitment Status

    Recruiting

  • First Posted

    December 11, 2017

  • Last update posted

    April 9, 2021

Study Description

Brief summary:

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Biological: BMS-986249
    Biological: Nivolumab
    Biological: Ipilimumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 425 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
  • Actual Study Start Date: December 2017
  • Estimated Primary Completion Date: September 2024
  • Estimated Study Completion Date: September 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1A: BMS-986249
Biological: BMS-986249
specified dose on specified day
Experimental: Part 1B: BMS-986249 + nivolumab (nivo)
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2A Arm B: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2B Cohort 1: BMS-986249 + nivo
Advanced hepatocellular carcinoma (HCC)
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 2A Arm E: Nivo
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Biological: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 2.5 years ]
  • 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2.5 years ]
  • 3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 2.5 years ]
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2.5 years ]
  • 5. Incidence of death [ Time Frame: Up to 4 years ]
  • 6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2.5 years ]
  • 7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 2.5 years ]
  • 8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 2.5 years ]
  • 9. Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
  • 10. Objective Response Rate as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2.5 years ]
  • Secondary Outcome Measures: 1. Cmax (Maximum observed serum concentration) [ Time Frame: Up to 2 years ]
  • 2. Tmax (Time of maximum observed concentration) [ Time Frame: Up to 2 years ]
  • 3. AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) [ Time Frame: Up to 2 years ]
  • 4. AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) [ Time Frame: Up to 2 years ]
  • 5. Ctau (Observed concentration at the end of a dosing interval) [ Time Frame: Up to 2 years ]
  • 6. Ctrough (Trough observed concentrations) [ Time Frame: Up to 2 years ]
  • 7. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 2 years ]
  • 8. Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 2 years ]
  • 9. Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] [ Time Frame: Up to 2 years ]
  • 10. Total body clearance (CLT) [ Time Frame: Up to 2 years ]
  • 11. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  • 12. Duration of response (DOR) [ Time Frame: Up to 4 years ]
  • 13. Progression-Free survival (PFS) [ Time Frame: Up to 4 years ]
  • 14. Time to response (TTR) [ Time Frame: Up to 4 years ]
  • 15. Incidence of Adverse Events (AEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  • 16. Incidence of Serious Adverse Events (SAEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  • 17. Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
  • 18. Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
  • 19. Incidence of clinically significant changes in clinical laboratory results: Hematology tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  • 20. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  • 21. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
  • 22. Time to Deterioration (TTD) in Part 2 of study [ Time Frame: Up to 4 Years ]

Eligibility Criteria

  • 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: - Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Some participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies - Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants - Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation - Willing and able to comply with all study procedures Exclusion Criteria: - Primary CNS malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded - Other active malignancy requiring concurrent intervention - Prior organ allograft - Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

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

United States, Colorado
University of Colorado - Cancer Center - PPDS
Aurora

United States, Colorado
Rocky Mountain Cancer Centers
Denver

United States, Florida
Baptist Health Medical Group Oncology LLC
Miami

United States, Maryland
Johns Hopkins University
Baltimore

United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack

United States, New York
Columbia University Medical Center (Cumc)
New York

United States, New York
Memorial Sloan Kettering Nassau
New York

United States, Ohio
University of Cincinnati Medical Center
Cincinnati

United States, Oregon
Willamette Valley Cancer Institute And Research Center
Eugene

United States, Pennsylvania
University of Pennsylvania
Philadelphia

United States, South Carolina
Greenville Health System
Greenville

United States, Texas
Texas Oncology-Austin Midtown
Austin

United States, Texas
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas

United States, Texas
MD Anderson Cancer Center
Houston

United States, Texas
Texas Oncology-San Antonio Medical Center
San Antonio

United States, Texas
Texas Oncology, P.A.
Tyler

United States, Virginia
Virginia Cancer Specialists (Leesburg) - USOR
Leesburg

United States, Virginia
Virginia Oncology Associates
Norfolk

United States, Washington
Northwest Cancer Specialists
Vancouver

Argentina, Distrito Federal
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Australia, New South Wales
Local Institution
North Sydney

Australia, South Australia
Local Institution
Adelaide

Australia, Victoria
Local Institution
Frankston

Australia, Victoria
Local Institution
Heidelberg

Canada, Alberta
Local Institution
Edmonton

Chile
Local Institution
Santiago

Finland
Local Institution
Helsinki

Germany
Local Institution
Essen

Germany
Local Institution
Hamburg

Germany
Local Institution
Heidelberg

Germany
Local Institution
Koeln

Italy
Local Institution
Milano

Italy
Local Institution
Napoli

Italy
Local Institution
Siena

Poland, Mazowieckie
Local Institution
Warszawa

Romania
Local Institution
Bucharest

Romania
Local Institution
Craiova

Spain
Local Institution
Badalona-barcelona

Spain
H. Univ. Vall dHebron
Barcelona

Spain
Fundacion Jimenez Diaz
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Malaga

Spain
Clinica Universidad de Navarra
Pamplona

Switzerland
Local Institution
Lausanne

Switzerland
Local Institution
Zuerich

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: NCT03369223 History of Changes
  • Other Study ID Numbers: CA030-001, 2018-000416-21
  • First Posted: December 11, 2017 Key Record Dates
  • Last Update Posted: April 9, 2021
  • Last Verified: April 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Physiological Effects of Drugs
    Antibodies, Monoclonal
    Nivolumab
    Immunologic Factors
    Antineoplastic Agents
    Antibodies