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

Phase 1

Terminated

• Conditions: Advanced Cancer
• Interventions: Drug: BMS-986299; Biological: Nivolumab; Biological: Ipilimumab

• Registration Number: NCT03444753
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-23
• Study Start: 2018-04-05
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-14
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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

Read More

Exclusion Criteria

• Primary CNS malignancy
• Participants with other active malignancy requiring concurrent intervention
• Uncontrolled or significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria apply

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	BMS-986299	BMS-986299
Arm B	BMS-986299	BMS-986299 in combination with nivolumab and ipilimumab
Arm B	Nivolumab	BMS-986299 in combination with nivolumab and ipilimumab
Arm B	Ipilimumab	BMS-986299 in combination with nivolumab and ipilimumab

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities (DLTs)	Up to 28 days
Incidence of clinical laboratory abnormalities	Approximately 2 years
Incidence of serious adverse events (SAEs)	Approximately 2 years
Incidence of AEs leading to discontinuation and deaths	Approximately 2 years
Incidence of adverse events (AEs)	Approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Approximately 2 years
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

Trial Locations

Locations (5)

Local Institution; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0003; 🇺🇸 La Jolla, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States