close-icon

Log In to Bolder Science

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number

By completing and submitting this form, you agree to allow Bolder Science to collect the information provided and to receive communications from Bolder Science in the future regarding disease education and research updates.

close-icon

Welcome and thank you for creating an account!

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.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

  • Clinicaltrials.gov identifier

    NCT03369223

  • Recruitment Status

    Recruiting

  • First Posted

    December 11, 2017

  • Last update posted

    May 3, 2022

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 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 days
Experimental: Part 1B: BMS-986249 + nivolumab (nivo)
Biological: BMS-986249
Specified dose on specified days

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 days

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 days

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 days

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 days

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

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 days

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 days

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. Number of participants with laboratory abnormalities [ Time Frame: Up to 2.5 years ]
  • 7. Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
  • 8. Objective Response Rate (ORR) 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. ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer) [ Time Frame: Up to 4 years ]
  • 5. Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  • 6. Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  • 7. Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  • 8. Incidence of AEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  • 9. Incidence of SAEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  • 10. Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
  • 11. Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
  • 12. Number of participants with clinical laboratory abnormalities Part 2 of study [ Time Frame: Up to 2.5 years ]
  • 13. 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

Inclusion Criteria: Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed. Eastern Cooperative Oncology Group Performance Status of 0 or 1 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 tumor type, if such a therapy exists Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants Willing and able to comply with all study procedures Exclusion Criteria: Primary central nervous system (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: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

Switzerland
Local Institution
Zuerich

Switzerland
Local Institution
Lausanne

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 - DFWW
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 - 0038
Buenos Aires

Argentina, Distrito Federal
Local Institution - 0052
Caba

Argentina
Local Institution - 0037
Buenos Aires

Australia, New South Wales
Local Institution - 0015
North Sydney

Australia, South Australia
Local Institution
Adelaide

Australia, Victoria
Local Institution
Frankston

Australia, Victoria
Austin Hospital
Heidelberg

Canada, Alberta
Local Institution
Edmonton

Canada
Local Institution - 0056
Ottawa

Chile, Metropolitana
Local Institution - 0036
Santiago

Finland
Local Institution - 0039
Helsinki

Germany
Local Institution
Essen

Germany
Local Institution
Hamburg

Germany
Local Institution
Heidelberg

Germany
Local Institution
Koeln

Italy
Local Institution
Milano

Italy
Local Institution - 0020
Napoli

Italy
Local Institution - 0049
Siena

Poland, Mazowieckie
Local Institution
Warszawa

Romania
Local Institution - 0045
Bucharest

Romania
Local Institution - 0041
Craiova

Spain, Madrid, Comunidad De
Local Institution - 0022
Madrid

Spain
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona

Spain
H. Univ. Vall dHebron
Barcelona

Spain
Local Institution - 0023
Madrid

Spain
Local Institution - 0050
Madrid

Spain
Hospital Universitario Virgen De La Victoria
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: NCT03369223 History of Changes
  • Other Study ID Numbers: CA030-001, 2018-000416-21
  • First Posted: December 11, 2017 Key Record Dates
  • Last Update Posted: May 3, 2022
  • Last Verified: April 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: Antibodies
    Antineoplastic Agents
    Immunologic Factors
    Nivolumab
    Antibodies, Monoclonal
    Physiological Effects of Drugs