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

NCT03369223 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CA030-0012018-000416-21
• Study Type: interventional
• Target: 356
• Locations: 11 countries
• Sites: 45

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

Conditions

Advanced Cancer

Keywords

Antibodies; Antineoplastic Agents; Immunologic Factors; Nivolumab; Antibodies, Monoclonal; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B

  Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

  From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

• Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B

  Dose-limiting toxicities (DLTs) were defined by the incidence, intensity, and duration of adverse events (AEs) possibly related to study treatment during the 5-week (35-day) DLT evaluation period for both BMS-986249 monotherapy and combination therapy. Participants who received at least 2 doses and completed or discontinued due to a DLT within this period were considered DLT-evaluable. Those who withdrew or received less than 2 doses for reasons other than a DLT were not DLT-evaluable and could be replaced. Any drug-related AE meeting DLT criteria resulted in discontinuation of study treatment. DLTs guided dose escalation and helped define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

  From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)

• Number of Participants Who Died - Part 1 A and 1 B

  Number of Participants who Died

  From enrollment until the date of death from any cause (up to approximately 83 months)

• Number of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B

  Number of Participants with Shifts from Baseline in Laboratory Tests

  From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

• Number of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B

  Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention required. Grade 5: Death related to the adverse event.

  From first dose until 24 weeks after first dose (up to approximately 24 weeks)

• Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F

  Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \<10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  From randomization until progression or death from any cause (up to approximately 83 months)

Secondary Outcomes (11)

• Time to Deterioration in Part 2A (Arm C, D and F)

  Approximately up to 6 months

• Safety Related Events in Part 2A (Arm C, D and F) and 2B

  From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

• BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2

  From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

• Progression Free Survival

  From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

• Duration of Response

  From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

Study Arms (11)

Part 1A: BMS-986249

EXPERIMENTAL

Biological: BMS-986249

Part 1B: BMS-986249 + nivolumab (nivo)

EXPERIMENTAL

Biological: BMS-986249; Biological: Nivolumab

Part 2A Arm C: BMS-986249 + nivo

EXPERIMENTAL

Previously untreated unresectable stage III-IV melanoma

Biological: BMS-986249; Biological: Nivolumab

Part 2A Arm D: ipilimumab + nivo then nivo

EXPERIMENTAL

Previously untreated unresectable stage III-IV melanoma

Biological: Nivolumab; Biological: Ipilimumab

Part 2A Arm F: BMS-986249 + nivo

EXPERIMENTAL

Previously untreated unresectable stage III-IV melanoma

Biological: BMS-986249; Biological: Nivolumab

Part 2B Cohort 1: BMS-986249 + nivo

EXPERIMENTAL

Advanced or intermediate hepatocellular carcinoma (HCC)

Biological: BMS-986249; Biological: Nivolumab

Part 2B Cohort 2: BMS-986249 + nivo

EXPERIMENTAL

Metastatic castration-resistant prostate cancer (CRPC)

Biological: BMS-986249; Biological: Nivolumab

Part 2B Cohort 3: BMS-986249 + nivo

EXPERIMENTAL

Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)

Biological: BMS-986249; Biological: Nivolumab

Part 2A Arm A: BMS-986249 + nivo then nivo

EXPERIMENTAL

* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm

Biological: BMS-986249; Biological: Nivolumab

Part 2A Arm B: BMS-986249 + nivo

EXPERIMENTAL

* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm

Biological: BMS-986249; Biological: Nivolumab

Part 2A Arm E: Nivo

EXPERIMENTAL

* Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm

Biological: Nivolumab

Interventions

BMS-986249 BIOLOGICAL

Specified dose on specified days

Part 1A: BMS-986249; Part 1B: BMS-986249 + nivolumab (nivo); Part 2A Arm A: BMS-986249 + nivo then nivo; Part 2A Arm B: BMS-986249 + nivo; Part 2A Arm C: BMS-986249 + nivo; Part 2A Arm F: BMS-986249 + nivo; Part 2B Cohort 1: BMS-986249 + nivo; Part 2B Cohort 2: BMS-986249 + nivo; Part 2B Cohort 3: BMS-986249 + nivo

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Part 1B: BMS-986249 + nivolumab (nivo); Part 2A Arm A: BMS-986249 + nivo then nivo; Part 2A Arm B: BMS-986249 + nivo; Part 2A Arm C: BMS-986249 + nivo; Part 2A Arm D: ipilimumab + nivo then nivo; Part 2A Arm E: Nivo; Part 2A Arm F: BMS-986249 + nivo; Part 2B Cohort 1: BMS-986249 + nivo; Part 2B Cohort 2: BMS-986249 + nivo; Part 2B Cohort 3: BMS-986249 + nivo

Ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: Yervoy, BMS-734016

Part 2A Arm D: ipilimumab + nivo then nivo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (45)

Local Institution - 0005

Aurora, Colorado, 80045, United States

Location

Local Institution - 0006

Denver, Colorado, 80218, United States

Location

Local Institution - 0017

Miami, Florida, 33176, United States

Location

Local Institution - 0024

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0001

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0002

New York, New York, 10032, United States

Location

Local Institution - 0003

New York, New York, 10065, United States

Location

Local Institution - 0029

Cincinnati, Ohio, 45219, United States

Location

Local Institution - 0013

Eugene, Oregon, 97401, United States

Location

Local Institution - 0004

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0008

Greenville, South Carolina, 29605, United States

Location

Local Institution - 0010

Austin, Texas, 78705-1165, United States

Location

Local Institution - 0009

Dallas, Texas, 75246, United States

Location

Local Institution - 0021

Houston, Texas, 77030, United States

Location

Local Institution - 0016

San Antonio, Texas, 78240, United States

Location

Local Institution - 0011

Tyler, Texas, 75702, United States

Location

Local Institution - 0012

Leesburg, Virginia, 20176, United States

Location

Local Institution - 0007

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0018

Vancouver, Washington, 98684, United States

Location

Local Institution - 0038

Buenos Aires, Distrito Federal, 1121, Argentina

Location

Local Institution - 0052

CABA, Distrito Federal, C1430, Argentina

Location

Local Institution - 0037

Buenos Aires, C1426ANZ, Argentina

Location

Local Institution - 0015

North Sydney, New South Wales, 2060, Australia

Location

Local Institution - 0014

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0025

Frankston, Victoria, 3199, Australia

Location

Local Institution - 0047

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0026

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0056

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0036

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0039

Helsinki, 00029, Finland

Location

Local Institution - 0030

Essen, 45147, Germany

Location

Local Institution - 0035

Hamburg, 20251, Germany

Location

Local Institution - 0031

Heidelberg, 69120, Germany

Location

Local Institution - 0048

Milan, 20133, Italy

Location

Local Institution - 0020

Napoli, 80131, Italy

Location

Local Institution - 0049

Siena, 53100, Italy

Location

Local Institution - 0040

Warsaw, 02-781, Poland

Location

Local Institution - 0045

Bucharest, 022328, Romania

Location

Local Institution - 0041

Craiova, 200542, Romania

Location

Local Institution - 0042

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0022

Madrid, Madrid, Comunidad de, 28027, Spain

Location

Local Institution - 0044

Barcelona, 08035, Spain

Location

Local Institution - 0023

Madrid, 28040, Spain

Location

Local Institution - 0050

Madrid, 28041, Spain

Location

Local Institution - 0043

Málaga, 29010, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 11, 2017
• Study Start: December 6, 2017
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Locations

AU (4); PL (1); RO (2); CL (1); AR (3); FI (1); IT (3); ES (6); US (19); CA (2); DE (3)