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An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
2 other identifiers
interventional
92
4 countries
16
Brief Summary
The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2018
Longer than P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2018
CompletedFirst Posted
Study publicly available on registry
February 26, 2018
CompletedStudy Start
First participant enrolled
March 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2024
CompletedResults Posted
Study results publicly available
September 18, 2025
CompletedSeptember 18, 2025
August 1, 2025
6.5 years
February 21, 2018
August 8, 2025
August 29, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect.
From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
Number of Participants Who Died During the Study
The number of participants who died during the study.
From first dose until death due to any cause (up to approximately 78 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects. A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period. Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.
From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)
Secondary Outcomes (9)
Objective Response Rate (ORR)
From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)
Median Duration of Response (mDOR)
From first dose until disease progression or death whichever occurred first (up to approximately 78 months)
Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months
At 6, 9, and 12 months after first dose
Maximum Plasma Concentration (Cmax) of BMS-986258
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
- +4 more secondary outcomes
Study Arms (4)
Part A Dose Escalation: BMS-986258
EXPERIMENTALPart A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
EXPERIMENTALPart B Dose Escalation: BMS-986258 + nivolumab
EXPERIMENTALPart C Cohort Expansion: BMS-986258 + nivolumab
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Histologic confirmation of one of the 5 tumors \[renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)\] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- 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
- Women must agree to follow specific methods of contraception, if applicable
You may not qualify if:
- Active, known or suspected autoimmune disease
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
- Other active malignancy requiring concurrent intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Local Institution - 0004
Los Angeles, California, 90033, United States
Local Institution - 0006
Los Angeles, California, 90033, United States
Local Institution - 0007
Aurora, Colorado, 80045, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242, United States
Local Institution - 0018
Ann Arbor, Michigan, 48109-5912, United States
Local Institution - 0010
Grand Rapids, Michigan, 49546, United States
Local Institution - 0012
Lebanon, New Hampshire, 03756, United States
Local Institution - 0016
Cincinnati, Ohio, 45267, United States
Local Institution - 0005
Pittsburgh, Pennsylvania, 15232, United States
Local Institution - 0002
Germantown, Tennessee, 38138, United States
Local Institution - 0013
Westmead, New South Wales, 2145, Australia
Local Institution - 0015
Melbourne, Victoria, 3084, Australia
Local Institution - 0014
Edmonton, Alberta, T6X 1E8, Canada
Local Institution - 0019
Vancouver, British Columbia, V5Z 4E6, Canada
Local Institution - 0009
Kobe, Hyōgo, 6500017, Japan
Local Institution - 0008
Chuo-ku, Tokyo, 1040045, Japan
Related Publications (1)
El Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12.
PMID: 33277223DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2018
First Posted
February 26, 2018
Study Start
March 8, 2018
Primary Completion
August 29, 2024
Study Completion
August 29, 2024
Last Updated
September 18, 2025
Results First Posted
September 18, 2025
Record last verified: 2025-08