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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03444753
• Other study ID #: CA039-001
• Status: Terminated
• Phase: Phase 1
• Start date: April 5, 2018
• Est. completion date: February 14, 2022

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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/exclusion criteria apply

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• BMS-986299
Specified dose on specified day

Biological:
• Nivolumab
Specified dose on specified day
• Ipilimumab
Specified dose on specified day

Locations

Country	Name	City	State
United States	Local Institution	Detroit	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	Local Institution - 0003	La Jolla	California
United States	Local Institution	New Haven	Connecticut
United States	Local Institution	Orange	California
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Portland	Oregon
United States	University of California Davis Medical Center	Sacramento	California
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs)		Up to 28 days
Primary	Incidence of adverse events (AEs)		Approximately 2 years
Primary	Incidence of clinical laboratory abnormalities		Approximately 2 years
Primary	Incidence of serious adverse events (SAEs)		Approximately 2 years
Primary	Incidence of AEs leading to discontinuation and deaths		Approximately 2 years
Secondary	Maximum observed plasma concentration (Cmax)		Approximately 2 years
Secondary	Time of maximum observed plasma concentration (Tmax)		Approximately 2 years
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]		Approximately 2 years
Secondary	Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]		Approximately 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls