A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

NCT03400332 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: CA027-0022023-509061-20
• Study Type: interventional
• Target: 281
• Locations: 12 countries
• Sites: 72

Brief Summary

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Conditions

Cancer; Melanoma

Outcome Measures

Primary Outcomes (7)

• Number of Participants Experiencing Adverse Events (AEs) - Part 1

  An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. This endpoint was prespecified in the protocol to include only participants in Part 1.

  From first dose up to 100 days after last dose (up to 65 months)

• Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1

  A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. This endpoint was prespecified in the protocol to include only participants in Part 1.

  From first dose up to 100 days after last dose (up to 65 months)

• Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1

  Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs. This endpoint was prespecified in the protocol to include only participants in Part 1.

  From first dose up to 100 days after last dose (up to 65 months)

• Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1

  Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. This endpoint was prespecified in the protocol to include only participants in Part 1.

  From first dose up to 100 days after last dose (up to 65 months)

• Number of Participants Who Died - Part 1

  The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.

  From first dose up to 100 days after last dose (up to 65 months)

• Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1

  Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. This endpoint was prespecified in the protocol to include only participants in Part 1.

  From first dose up to 30 days after last dose (up to 63 months)

• Objective Response Rate (ORR) - Part 2

  Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.

  From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)

Secondary Outcomes (22)

• Objective Response Rate (ORR) - Part 1

  From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)

• Duration of Response (DOR) - Part 1

  From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)

• Maximum Concentration (Cmax) - Part 1

  Cycle 1 Day 1

• AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1

• AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1

  Cycle 1 Day 1

Study Arms (5)

Part 1A: BMS-986253 + nivolumab

EXPERIMENTAL

Drug: BMS-986253; Biological: Nivolumab

Part 1B: BMS-986253 + nivolumab

EXPERIMENTAL

Drug: BMS-986253; Biological: Nivolumab

Part 1C: BMS-986253 + nivolumab + ipilimumab

EXPERIMENTAL

Drug: BMS-986253; Biological: Nivolumab; Biological: Ipilimumab

Part 2A: BMS-986253 + nivolumab + ipilimumab

EXPERIMENTAL

Drug: BMS-986253; Biological: Nivolumab; Biological: Ipilimumab

Part 2B: Placebo + nivolumab + ipilimumab

PLACEBO COMPARATOR

Biological: Nivolumab; Biological: Ipilimumab; Other: Placebo

Interventions

Placebo OTHER

Specified dose on specified days

Part 2B: Placebo + nivolumab + ipilimumab

BMS-986253 DRUG

Specified dose on specified days

Part 1A: BMS-986253 + nivolumab; Part 1B: BMS-986253 + nivolumab; Part 1C: BMS-986253 + nivolumab + ipilimumab; Part 2A: BMS-986253 + nivolumab + ipilimumab

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Part 1A: BMS-986253 + nivolumab; Part 1B: BMS-986253 + nivolumab; Part 1C: BMS-986253 + nivolumab + ipilimumab; Part 2A: BMS-986253 + nivolumab + ipilimumab; Part 2B: Placebo + nivolumab + ipilimumab

Ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-734016, YERVOY

Part 1C: BMS-986253 + nivolumab + ipilimumab; Part 2A: BMS-986253 + nivolumab + ipilimumab; Part 2B: Placebo + nivolumab + ipilimumab

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 per RECIST v1.1
• At least 1 lesion accessible for biopsy
• Eastern Cooperative Oncology Group Performance Status of 0 or 1

You may not qualify if:

• Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
• Participants with active, known or suspected autoimmune disease
• Participants with conditions requiring systemic treatment with either corticosteroids (\> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
• Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (72)

Local Institution - 0059

Springdale, Arkansas, 72762, United States

Location

Local Institution - 0099

Los Angeles, California, 90033, United States

Location

Local Institution - 0007

Lakewood, Colorado, 80228, United States

Location

Local Institution - 0087

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0100

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0101

Marietta, Georgia, 30060, United States

Location

Local Institution - 0012

Columbia, Maryland, 21044, United States

Location

Local Institution - 0003

Lutherville, Maryland, 21093, United States

Location

Local Institution - 0060

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0004

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0076

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers Of Nevada

Las Vegas, Nevada, 89169, United States

Location

Local Institution - 0005

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0032

New Brunswick, New Jersey, 08903, United States

Location

Local Institution - 0025

New York, New York, 10029, United States

Location

Local Institution - 0002

New York, New York, 10032, United States

Location

Local Institution - 0028

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 0017

Eugene, Oregon, 97401, United States

Location

Local Institution - 0001

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0009

Greenville, South Carolina, 29615, United States

Location

Local Institution - 0011

Austin, Texas, 78705, United States

Location

Local Institution - 0010

Dallas, Texas, 75246, United States

Location

Local Institution - 0014

Fort Worth, Texas, 76104-3927, United States

Location

Local Institution - 0018

Houston, Texas, 77030, United States

Location

Local Institution - 0006

San Antonio, Texas, 78240, United States

Location

Local Institution - 0013

Tyler, Texas, 75702, United States

Location

Local Institution - 0058

Salt Lake City, Utah, 84112, United States

Location

Local Institution - 0015

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0008

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0088

Wollstonecraft, New South Wales, 2065, Australia

Location

Local Institution - 0096

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0090

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 0095

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 0097

Perth, Western Australia, 6009, Australia

Location

Local Institution - 0091

Ballarat Central, VIC 3350, Australia

Location

Local Institution - 0037

Brussels, 1200, Belgium

Location

Local Institution - 0036

Ghent, 9000, Belgium

Location

Local Institution - 0082

Kortrijk, 8500, Belgium

Location

Local Institution - 0030

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0029

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0078

Victoria, British Columbia, V8R 6V5, Canada

Location

Local Institution - 0020

Toronto, Ontario, M5G 1Z5, Canada

Location

Local Institution - 0055

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0056

Montreal, Quebec, H2X 0A9, Canada

Location

Local Institution - 0067

Marseille, Bouches-du-Rhône, 13385, France

Location

Local Institution - 0085

Nantes, 44000, France

Location

Local Institution - 0068

Paris, 75010, France

Location

Local Institution - 0102

Toulouse, 31059, France

Location

Local Institution - 0069

Villejuif, 94800, France

Location

Local Institution - 0054

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Local Institution - 0052

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Local Institution - 0034

Berlin, 12200, Germany

Location

Local Institution - 0053

Hamburg, 20251, Germany

Location

Local Institution - 0043

Forlì, 47014, Italy

Location

Local Institution - 0042

Milan, 20132, Italy

Location

Local Institution - 0027

Naples, 80131, Italy

Location

Local Institution - 0026

Rozzano-milano, 20089, Italy

Location

Local Institution - 0071

Krakow, 31-115, Poland

Location

Local Institution - 0077

Warsaw, 02-781, Poland

Location

Local Institution - 0045

Madrid, 28034, Spain

Location

Local Institution - 0022

Madrid, 28040, Spain

Location

Local Institution - 0023

Madrid, 28050, Spain

Location

Local Institution - 0044

Málaga, 29010, Spain

Location

Local Institution - 0021

Pamplona, 31008, Spain

Location

Local Institution - 0047

Santiago de Compostela, 15706, Spain

Location

Local Institution - 0049

Lund, 221 85, Sweden

Location

Local Institution - 0040

Lausanne, 1011, Switzerland

Location

Local Institution - 0041

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 0039

Zurich, 8091, Switzerland

Location

Local Institution - 0024

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0083

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

Local Institution - 0019

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Neoplasms; Melanoma

Interventions

HuMax-IL8; Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 17, 2018
• Study Start: February 12, 2018
• Primary Completion: April 26, 2024
• Study Completion: December 4, 2025
• Last Updated: February 24, 2026
• Results First Posted: June 19, 2025

Record last verified: 2026-01

Locations

FR (5); GB (3); ES (6); CA (6); PL (2); IT (4); AU (6); US (29); SE (1); BE (3); CH (3); DE (4)