A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02341625
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.

Key Dates

Start date
Jun 19, 2015
Status verified
Jul 2022
Primary completion
Feb 25, 2019
Completion
May 7, 2020

Study Design

Enrollment
126 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Ascending dose of BMS-986148
    BMS-986148 Intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. Alternate dose and schedules may be explored.
  • Experimental: Part 2: Expansion dose of BMS-986148
    BMS-986148 Intravenous injection of Maximum tolerated dose (MTD) on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
  • Experimental: Part 3A: Ascending dose of BMS-986148
    Set dose of nivolumab and BMS-986148 intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
  • Experimental: Part 3B: Expansion dose of BMS-986148
    Set dose of nivolumab and BMS-986148 intravenous injection at or below maximum tolerated dose on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.

Primary Outcome Measure

Number of Participants With Adverse Events at Worst CTC Grade [ Time Frame: From first dose to up to 100 days post last dose (Up to 6 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Moores Cancer CenterLa JollaCalifornia92093-0698-
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in La Jolla, CA

By research site
Moores Cancer Center· La Jolla, CADuke University Medical Center· Durham, NC

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