An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

NCT ID: NCT03444753

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2022-02-14

Brief Summary

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The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

BMS-986299

Group Type EXPERIMENTAL

BMS-986299

Intervention Type DRUG

Specified dose on specified day

Arm B

BMS-986299 in combination with nivolumab and ipilimumab

Group Type EXPERIMENTAL

BMS-986299

Intervention Type DRUG

Specified dose on specified day

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified day

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified day

Interventions

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BMS-986299

Specified dose on specified day

Intervention Type DRUG

Nivolumab

Specified dose on specified day

Intervention Type BIOLOGICAL

Ipilimumab

Specified dose on specified day

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo BMS-936558 Yervoy BMS-734016

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* IO therapy resistant or insensitive tumors
* Have at least 2 tumor lesions accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria

* Primary CNS malignancy
* Participants with other active malignancy requiring concurrent intervention
* Uncontrolled or significant cardiovascular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0003

La Jolla, California, United States

Site Status

Local Institution

Orange, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

Local Institution

New Haven, Connecticut, United States

Site Status

Local Institution

Detroit, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Local Institution

Portland, Oregon, United States

Site Status

Local Institution

Pittsburgh, Pennsylvania, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Nelson BE, O'Brien S, Sheth RA, Hong DS, Naing A, Zhang X, Xu A, Hamuro L, Suryawanshi R, McKinley D, Novosiadly RD, Piha-Paul SA. Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors. J Immunother Cancer. 2025 Jan 16;13(1):e010013. doi: 10.1136/jitc-2024-010013.

Reference Type DERIVED
PMID: 39824531 (View on PubMed)

Related Links

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Other Identifiers

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CA039-001

Identifier Type: -

Identifier Source: org_study_id

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