An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

ClinicalTrials.gov ID

NCT03446040

Acronym / sponsor ID

CA031-002

Conditions

Advanced Cancer

Phase

Phase 1/2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Business objectives have changed

Enrolment

92 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

8 Mar 2018 (actual)

Primary completion

29 Aug 2024 (actual)

Study completion

29 Aug 2024 (actual)

First posted

26 Feb 2018 (actual)

Results

Posted 18 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

4

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Adverse Events (AEs)

   Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)

   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.

2. Number of Participants Who Died During the Study

   Time frame: From first dose until death due to any cause (up to approximately 78 months)

   The number of participants who died during the study.

3. Number of Participants With Dose Limiting Toxicities (DLTs)

   Time frame: From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 33277223El 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.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

16 sites in 4 countries: see every site and its status.