An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

Last updated: October 4, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

1/2

Condition

Metastatic Cancer

Treatment

Nivolumab

BMS-986288

Regorafenib

Clinical Study ID

NCT03994601
CA043-001
2021-004284-27
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have atleast 1 lesion accessible for biopsy

  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

  • Received, and then progressed, relapsed, or been intolerant to, at least 1 standardtreatment regimen in the advanced or metastatic setting according to select solidtumor histologies

Exclusion

Exclusion Criteria:

  • Active, known or suspected autoimmune disease

  • Active malignancy requiring concurrent intervention

  • Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis asthe only site of disease, will be excluded

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 219
Treatment Group(s): 3
Primary Treatment: Nivolumab
Phase: 1/2
Study Start date:
September 06, 2019
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Local Institution - 0011

    Ciudad Autónoma De Buenos Aires, Buenos Aires 1426
    Argentina

    Site Not Available

  • Local Institution - 0074

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1096AAS
    Argentina

    Site Not Available

  • Instituto Oncológico de Córdoba

    Córdoba, Cordoba X5000HXL
    Argentina

    Active - Recruiting

  • Local Institution - 0014

    Córdoba, Cordoba X5000HXL
    Argentina

    Site Not Available

  • Instituto Medico Rio Cuarto S.A.

    Río Cuarto, Cordoba 5800
    Argentina

    Active - Recruiting

  • Local Institution - 0013

    Río Cuarto, Cordoba 5800
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    ABB, Distrito Federal C1199
    Argentina

    Active - Recruiting

  • Local Institution - 0008

    ABB, Distrito Federal C1199
    Argentina

    Site Not Available

  • Local Institution - 0012

    Caba, Distrito Federal C1430
    Argentina

    Site Not Available

  • Local Institution

    Capital, Distrito Federal C1280
    Argentina

    Site Not Available

  • Cemic

    Buenos Aires, 1431
    Argentina

    Active - Recruiting

  • Hospital Britanico De Buenos Aires

    Buenos Aires, C1280AEB
    Argentina

    Active - Recruiting

  • Local Institution - 0016

    Buenos Aires, C1280AEB
    Argentina

    Site Not Available

  • Local Institution - 0017

    Buenos Aires, 1431
    Argentina

    Site Not Available

  • Local Institution

    Cordoba, 5000
    Argentina

    Site Not Available

  • Local Institution - 0048

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Local Institution - 0006

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Local Institution - 0041

    Laval, Quebec H7M 3L9
    Canada

    Site Not Available

  • Local Institution - 0046

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Local Institution - 0042

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Local Institution

    Recoleta, Metropolitana
    Chile

    Site Not Available

  • Bradfordhill

    Santiago, Metropolitana 8420383
    Chile

    Active - Recruiting

  • Local Institution - 0009

    Santiago, Metropolitana 8420383
    Chile

    Site Not Available

  • Local Institution - 0019

    Santiago, Metropolitana 7510032
    Chile

    Site Not Available

  • Local Institution - 0035

    Santiago, Metropolitana 7620002
    Chile

    Site Not Available

  • Clínica UC San Carlos de Apoquindo

    Santiago, Región Metropolitana De Santiago 7620002
    Chile

    Active - Recruiting

  • FALP

    Santiago, Región Metropolitana De Santiago 7500921
    Chile

    Active - Recruiting

  • Local Institution - 0036

    Santiago, Región Metropolitana De Santiago 7500921
    Chile

    Site Not Available

  • Local Institution - 0010

    Viña del Mar, Valparaiso 2520598
    Chile

    Site Not Available

  • Oncocentro Apys

    Viña del Mar, Valparaiso 2520598
    Chile

    Active - Recruiting

  • Local Institution - 0034

    Bordeaux, Gironde 33075
    France

    Site Not Available

  • Hopital Nord Guillaume-et-Rene-Laennec / CHU de Nantes

    Saint-Herblain, Loire-Atlantique 44800
    France

    Active - Recruiting

  • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

    Saint-Herblain, Loire-Atlantique 44800
    France

    Active - Recruiting

  • Local Institution - 0022

    Saint-Herblain, Loire-Atlantique 44800
    France

    Site Not Available

  • Local Institution

    Bron, 69500
    France

    Site Not Available

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron Cedex, 69677
    France

    Active - Recruiting

  • Local Institution - 0018

    Bron Cedex, 69677
    France

    Site Not Available

  • Local Institution

    Lyon, 69003
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord

    Marseille, 13915
    France

    Active - Recruiting

  • Local Institution - 0026

    Marseille, 13915
    France

    Site Not Available

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • Local Institution - 0015

    Paris, 75248
    France

    Site Not Available

  • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

    Toulon, 83100
    France

    Site Not Available

  • Local Institution

    Toulon Cedex, 83056
    France

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardia 20133
    Italy

    Active - Recruiting

  • Local Institution - 0040

    Milan, Lombardia 20133
    Italy

    Site Not Available

  • Local Institution - 0038

    Padova, Veneto 35128
    Italy

    Site Not Available

  • Local Institution - 0028

    Ancona, 60126
    Italy

    Site Not Available

  • Azienda Ospedaliera Mater Domini-Translational Oncology Unit

    Catanzaro, 88100
    Italy

    Active - Recruiting

  • Local Institution - 0033

    Catanzaro, 88100
    Italy

    Site Not Available

  • Local Institution - 0031

    Milan, 20162
    Italy

    Site Not Available

  • Local Institution

    Milano, 20162
    Italy

    Site Not Available

  • Local Institution

    Monza, 20900
    Italy

    Site Not Available

  • Local Institution - 0027

    Monza, 20900
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Active - Recruiting

  • Local Institution - 0039

    Roma, 00168
    Italy

    Site Not Available

  • Local Institution - 0056

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0054

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre-Medical Oncology

    Madrid, 28041
    Spain

    Active - Recruiting

  • Local Institution - 0023

    Madrid, 28041
    Spain

    Site Not Available

  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology

    Majadahonda, 28222
    Spain

    Active - Recruiting

  • Local Institution - 0024

    Majadahonda, 28222
    Spain

    Site Not Available

  • Local Institution - 0055

    Sevilla, 41013
    Spain

    Site Not Available

  • Local Institution

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe-ONCOLOGY DEPARTMENT

    València, 46026
    Spain

    Active - Recruiting

  • Local Institution - 0025

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0075

    Costa Mesa, California 92627
    United States

    Site Not Available

  • University of California, Irvine (UCI) Health Cancer Center - Newport/Costa Mesa

    Costa Mesa, California 92627
    United States

    Active - Recruiting

  • Local Institution - 0050

    Orange, California 92868-3201
    United States

    Site Not Available

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center

    Orange, California 92868
    United States

    Active - Recruiting

  • Local Institution - 0053

    Stanford, California 94305
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Local Institution - 0005

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University Of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Local Institution - 0069

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Florida College of Medicine

    Gainesville, Florida 32610
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Local Institution - 0051

    Orlando, Florida 32804
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Local Institution - 0002

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Local Institution - 0004

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0001

    Hackensack, New Jersey 07601
    United States

    Site Not Available

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