An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02658890
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

Key Dates

Start date
Apr 14, 2016
Status verified
Aug 2023
Primary completion
Oct 26, 2021
Completion
Oct 26, 2021

Study Design

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

Arms

  • Experimental: Combination Therapy (Dose Escalation)
    BMS 986205 + Nivolumab specified dose at specified intervals.
  • Experimental: Combination Therapy (Dose Expansion)
    BMS 986205 + Nivolumab specified dose at specified intervals.
  • Experimental: Combination Therapy 2 (Dose Expansion)
    BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals

Primary Outcome Measure

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths [ Time Frame: From first dose to 100 days after last dose (up to 15 months) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Local Institution - 0028TucsonArizona85724-5024-
Local Institution - 0026La JollaCalifornia92093-0698-
Local Institution - 0035TampaFlorida33612-9497-
Local Institution - 0005AtlantaGeorgia30322-
Local Institution - 0048AtlantaGeorgia30342-
Local Institution - 0027ChicagoIllinois60637-
Local Institution - 0051LuthervilleMaryland21093-
Local Institution - 0049DetroitMichigan48201-
Local Institution - 0006St LouisMissouri63110-
Local Institution - 0033HackensackNew Jersey07601-
Local Institution - 0041New YorkNew York10016-
Local Institution - 0030ClevelandOhio44195-
Local Institution - 0034PhiladelphiaPennsylvania19111-2412-
Local Institution - 0057PittsburghPennsylvania15232-
Local Institution - 0043NashvilleTennessee37232-

Find similar trials in Tucson, AZ

By condition
MelanomaLung cancer
By specialty
OncologySkin cancerDermatologyLung oncologyLung disease
By research site
Local Institution - 0028· Tucson, AZLocal Institution - 0026· La Jolla, CALocal Institution - 0035· Tampa, FLLocal Institution - 0005· Atlanta, GALocal Institution - 0048· Atlanta, GALocal Institution - 0027· Chicago, IL

Related Studies