A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03184870
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BMS-813160 — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Nab-paclitaxel — DRUG
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days
  • 5-fluorouracil (5-FU) — DRUG
    Specified dose on specified days
  • Leucovorin — DRUG
    Specified dose on specified days
  • Irinotecan — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.

Key Dates

Start date
Aug 8, 2017
Status verified
Sep 2025
Primary completion
Apr 6, 2023
Completion
Jun 14, 2023

Study Design

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

Arms

  • Experimental: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
    FOLFIRI: FOL (folinic acid \[leucovorin\]) F (fluorouracil \[5-fluorouracil\]) IRI (irinotecan \[CAMPTOSAR\])
  • Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
  • Experimental: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
    2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable
  • Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
  • Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
  • Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
  • Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
  • Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
  • Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel
  • Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab
  • Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab
  • Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy
  • Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy

Primary Outcome Measure

Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose up to 100 days post last dose, up to approximately 3 years ]

Locations (28)

FacilityCityStateZIPSite coordinators
Local Institution - 0003BirminghamAlabama35249-
Local Institution - 0026PhoenixArizona85054-
Local Institution - 0002Los AngelesCalifornia90033-
Local Institution - 0025Los AngelesCalifornia90033-
Local Institution - 0041OrangeCalifornia92868-3201-
Local Institution - 0015AuroraColorado80045-
Local Institution - 0018Washington D.C.District of Columbia20007-
Local Institution - 0048BrooksvilleFlorida34613-
Local Institution - 0047St. PetersburgFlorida33705-
Local Institution - 0005BaltimoreMaryland21287-
Local Institution - 0033BostonMassachusetts02114-
Local Institution - 0027RochesterMinnesota55905-0001-
Local Institution - 0039HattiesburgMississippi39401-
Local Institution - 0023St LouisMissouri63110-
Local Institution - 0004HackensackNew Jersey07601-
Local Institution - 0017New YorkNew York10065-
Local Institution - 0024RochesterNew York14642-
Local Institution - 0046CharlotteNorth Carolina28204-
Local Institution - 0021ClevelandOhio44195-
Local Institution - 0044ClevelandOhio44106-5055-
Local Institution - 0037AllentownPennsylvania18103-
Local Institution - 0014PhiladelphiaPennsylvania19104-
Local Institution - 0020PhiladelphiaPennsylvania19107-
Local Institution - 0045CharlestonSouth Carolina29425-
Local Institution - 0034NashvilleTennessee37203-
Local Institution - 0038NashvilleTennessee37232-
Local Institution - 0016Salt Lake CityUtah84112-
Local Institution - 0042CharlottesvilleVirginia22908-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
Local Institution - 0003· Birmingham, ALLocal Institution - 0026· Phoenix, AZLocal Institution - 0002· Los Angeles, CALocal Institution - 0025· Los Angeles, CALocal Institution - 0041· Orange, CALocal Institution - 0015· Aurora, CO

Related Studies