An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02737475
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • BMS-986178 — DRUG
    Specified dose on specified days
  • Nivolumab — DRUG
    Specified dose on specified days
  • Ipilimumab — DRUG
    Specified dose on specified days
  • Tetanus vaccine — BIOLOGICAL
    Specified dose on specified days
  • DPV-001 vaccine — BIOLOGICAL
    DPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days

Study Details

The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in participants with solid cancers that are advanced or have spread.

Key Dates

Start date
Jun 17, 2016
Status verified
Dec 2021
Primary completion
Nov 2, 2020
Completion
Nov 2, 2020

Study Design

Enrollment
166 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    * BMS-986178 at specified doses at specified intervals * Enrollment is closed for this arm
  • Experimental: Part 2: Dose Escalation and Expansion
    * BMS-986178 in combination with Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
  • Experimental: Part 3: Dose Escalation and Expansion
    * BMS-986178 in combination with Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm
  • Experimental: Part 4: Dose Schedule and Exploration
    * BMS-986178/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
  • Experimental: Part 5: Dose Schedule and Exploration
    * BMS-986178/Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm
  • Experimental: Part 6: Dose Safety and Expansion
    * BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
  • Experimental: Part 7: Dose Safety and Expansion
    * BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
  • Experimental: Part 8: Dose Exploration
    * BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval * Enrollment is closed for this arm
  • Experimental: Part 9: Dose Exploration
    * BMS-986178/Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 1) at specified doses at specified intervals OR Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 2) at specified doses at specified intervals * Enrollment is open for this arm \[Tumor type triple negative breast cancer (TNBC)\]

Primary Outcome Measure

The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: From first dose to 28 days after first dose ]

Locations (8)

FacilityCityStateZIPSite coordinators
University Of ColoradoAuroraColorado80045-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Cancer InstituteBuffaloNew York14263-
Columbia University Medical Center (Cumc)New YorkNew York10032-
Oregon Health & Science UniversityPortlandOregon97239-
Providence Portland Medical CenterPortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Aurora, CO

By research site
University Of Colorado· Aurora, COGeorgetown University Medical Center· Washington D.C., DCJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJRoswell Park Cancer Institute· Buffalo, NYColumbia University Medical Center (Cumc)· New York, NYOregon Health & Science University· Portland, OR

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