A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Study at a glance

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

Official title

A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer

ClinicalTrials.gov ID

NCT05543629

Acronym / sponsor ID

CA115-001

Conditions

Advanced Solid Tumors, Non-small Cell Lung Cancer

Keywords

BMS-986442, Nivolumab, Chemotherapy

Phase

Phase 1/2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Business objectives have changed

Enrolment

36 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

4 Oct 2022 (actual)

Primary completion

12 Sep 2024 (actual)

Study completion

12 Sep 2024 (actual)

First posted

16 Sep 2022 (actual)

Results

Posted 18 Mar 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

Randomised

Intervention model

Sequential

Masking

None (open label)

Number of arms

6

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

   Time frame: From first dose to 100 days post last dose (Approximately 6 Months)

   Number of Participants with Adverse Events. 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 that does not necessarily have a causal relationship with this treatment. An AE can therefore 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. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

2. Number of Participants With Serious Adverse Events

   Time frame: From first dose to 100 days post last dose (Approximately 6 Months)

   A serious adverse event (SAE) is defined as 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; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization

3. Number of Participants With Adverse Events Leading to Discontinuation

   Time frame: From first dose to 100 days post last dose (Approximately 6 Months)

   Number of Participants with adverse events leading to discontinuation

4. Number of Participants With Dose Limiting Toxicities

   Time frame: From Cycle 1 day 1 to day 28 (28 Days)

   DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade ≥ 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of > 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.

5. Number of Participants Who Died

   Time frame: From first dose to 100 days post last dose (Approximately 6 Months)

   Number of Participants who died

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• BMS Clinical Trial InformationLink provided by the sponsor.
• FDA Safety Alerts and RecallsLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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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.

32 sites in 5 countries: see every site and its status.