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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Cancer
• Intervention / Treatment: Biological: Ipilimumab; Biological: Nivolumab; Drug: BMS-986299

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0698
      • Local Institution - 0003
    • Orange, California, United States, 92868
      • Local Institution
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Local Institution
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Local Institution
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Local Institution
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232-1305
      • Local Institution
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; BMS-986299	Drug: BMS-986299; Specified dose on specified day
Experimental: Arm B; BMS-986299 in combination with nivolumab and ipilimumab	Biological: Ipilimumab; Specified dose on specified day; Other Names: BMS-734016; Yervoy; Biological: Nivolumab; Specified dose on specified day; Other Names: BMS-936558; Opdivo; Drug: BMS-986299; Specified dose on specified day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose-limiting toxicities (DLTs)	Up to 28 days
Incidence of adverse events (AEs)	Approximately 2 years
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): February 14, 2022

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab
• Other Study ID Numbers: CA039-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No