An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03661632
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • BMS-986310 — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.

Key Dates

Start date
Sep 11, 2018
Status verified
Oct 2021
Primary completion
Nov 11, 2019
Completion
Dec 29, 2020

Study Design

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

Arms

  • Experimental: Dose Escalation
    Part 1: BMS-986310 + Nivolumab Combination Dose Escalation Sub-Study A: A cohort of Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy. Sub-Study B: A cohort of PD\[L\]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab
  • Experimental: Cohort Expansion
    Part 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1. BMS-986310 + Nivolumab combination will be administered in specific patient populations.

Primary Outcome Measure

Incidence of Adverse Events (AE) [ Time Frame: up to 3 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
UPMC Hillman Cancer CenterPittsburghPennsylvania15213-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MOHackensack University Medical Center· Hackensack, NJUPMC Hillman Cancer Center· Pittsburgh, PAMD Anderson Cancer Center· Houston, TX

Related Studies