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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

A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444753
Enrollment
82
Registered
2018-02-23
Start date
2018-04-05
Completion date
2022-02-14
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Brief summary

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.

Interventions

DRUGBMS-986299

Specified dose on specified day

BIOLOGICALNivolumab

Specified dose on specified day

BIOLOGICALIpilimumab

Specified dose on specified day

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Incidence of AEs leading to discontinuation and deathsApproximately 2 years
Incidence of dose-limiting toxicities (DLTs)Up to 28 days
Incidence of adverse events (AEs)Approximately 2 years
Incidence of clinical laboratory abnormalitiesApproximately 2 years
Incidence of serious adverse events (SAEs)Approximately 2 years

Secondary

MeasureTime frame
Time of maximum observed plasma concentration (Tmax)Approximately 2 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]Approximately 2 years
Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]Approximately 2 years
Maximum observed plasma concentration (Cmax)Approximately 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026