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TerminatedNCT03444753Updated May 23, 2022

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 1 interventional study of BMS-986299 and Nivolumab in Advanced Cancer, sponsored by Bristol-Myers Squibb. Terminated at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Why this study was terminated
business objectives have changed
Phase
Phase 1
Study type
Interventional
Enrollment
82
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Arm A

    BMS-986299

    Drug: BMS-986299

  • Experimental
    Arm B

    BMS-986299 in combination with nivolumab and ipilimumab

    Drug: BMS-986299 · Biological: Nivolumab · Biological: Ipilimumab

Interventions

  • DrugBMS-986299

    Specified dose on specified day

  • BiologicalNivolumab

    Specified dose on specified day

    Also known as: Opdivo, BMS-936558

  • BiologicalIpilimumab

    Specified dose on specified day

    Also known as: Yervoy, BMS-734016

05

What researchers measure

Primary outcomes

  1. Incidence of dose-limiting toxicities (DLTs)

    Time frame: Up to 28 days

  2. Incidence of adverse events (AEs)

    Time frame: Approximately 2 years

  3. Incidence of clinical laboratory abnormalities

    Time frame: Approximately 2 years

  4. Incidence of serious adverse events (SAEs)

    Time frame: Approximately 2 years

  5. Incidence of AEs leading to discontinuation and deaths

    Time frame: Approximately 2 years

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Approximately 2 years

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Approximately 2 years

  3. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Approximately 2 years

  4. Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]

    Time frame: Approximately 2 years

06

Study locations

9 sites
  • Local Institution - 0003
    La Jolla, California 92093-0698, United States
  • Local Institution
    Orange, California 92868, United States
  • University of California Davis Medical Center
    Sacramento, California 95817, United States
  • Local Institution
    New Haven, Connecticut 06520, United States
  • Local Institution
    Detroit, Michigan 48202, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Local Institution
    Portland, Oregon 97239, United States
  • Local Institution
    Pittsburgh, Pennsylvania 15232-1305, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03444753
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Apr 5, 2018
Primary completion
Feb 14, 2022
Completion
Feb 14, 2022
Last update
May 23, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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