Summary

for people ages 18–100 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Keywords

Advanced Cancer Melanoma Non-Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Nivolumab Antibodies, Monoclonal BMS-986205 Ipilimumab

Eligibility

For people ages 18–100

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation,please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
  • During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
  • Subjects must have measurable disease
  • Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
  • At least 4 weeks since any previous treatment for cancer
  • Must be able to swallow pills or capsules
  • Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Exclusion Criteria:

  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
  • Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
  • Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
  • Active infection

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla, California, 92093-0698, United States
  • Local Institution withdrawn
    Phoenix, Arizona, 85054, United States
  • University of Arizona Cancer Center accepting new patients
    Tucson, Arizona, 85724, United States
  • Local Institution accepting new patients
    Vancouver, British Columbia, V5Z 4E6, Canada
  • Local Institution accepting new patients
    Edmonton, Alberta, T6G 1Z2, Canada
  • Local Institution withdrawn
    Rochester, Minnesota, 55905, United States
  • Washington University accepting new patients
    Saint Louis, Missouri, 63110, United States
  • University Of Chicago accepting new patients
    Chicago, Illinois, 60637, United States
  • Vanderbilt University Medical Center accepting new patients
    Nashville, Tennessee, 37232, United States
  • Northside Hospital, Inc accepting new patients
    Atlanta, Georgia, 30342, United States
  • Emory Winship Cancer Institute accepting new patients
    Atlanta, Georgia, 30322, United States
  • Barbara Ann Karmanos Cancer Institute accepting new patients
    Detroit, Michigan, 48201, United States
  • Cleveland Clinic accepting new patients
    Cleveland, Ohio, 44195, United States
  • H. Lee Moffitt Cancer Center accepting new patients
    Tampa, Florida, 33612-9497, United States
  • Local Institution withdrawn
    Jacksonville, Florida, 32224, United States
  • UPMC Cancer Center accepting new patients
    Pittsburgh, Pennsylvania, 15213, United States
  • Local Institution accepting new patients
    Toronto, Ontario, M5G 2M9, Canada
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins accepting new patients
    Lutherville, Maryland, 21093, United States
  • Fox Chase Cancer Center accepting new patients
    Philadelphia, Pennsylvania, 19111-2412, United States
  • Hackensack University Medical Center accepting new patients
    Hackensack, New Jersey, 07601, United States
  • New York University accepting new patients
    New York, New York, 10016, United States
  • Local Institution accepting new patients
    Greenfield Park, Quebec, J4V 2H1, Canada
  • Local Institution accepting new patients
    Montreal, Quebec, H3T 1E2, Canada
  • Local Institution accepting new patients
    Oslo, 0424, Norway
  • Local Institution accepting new patients
    Solna, 171 64, Sweden
  • Local Institution withdrawn
    Helsinki, 00029, Finland
  • Local Institution accepting new patients
    Helsinki, 00180, Finland
  • Local Institution accepting new patients
    Lille CEDEX, 59037, France
  • Local Institution accepting new patients
    Lyon Cedex 08, 69373, France
  • Local Institution accepting new patients
    Marseille Cedex 5, 13385, France
  • Local Institution accepting new patients
    Nantes Cedex 01, 44093, France
  • Local Institution accepting new patients
    Paris, 75005, France
  • Local Institution accepting new patients
    Toulouse, 31100, France
  • Local Institution accepting new patients
    Villejuif, 94800, France
  • Universitatsklinikum Essen accepting new patients
    Essen, 45147, Germany
  • Klinikum Am Gesundbrunnen accepting new patients
    Heilbronn, 74078, Germany
  • Local Institution accepting new patients
    Barcelona, 08035, Spain
  • Local Institution accepting new patients
    Madrid, 28040, Spain
  • Local Institution accepting new patients
    Madrid, 28050, Spain
  • Oddzial Badan Wczesnych Faz accepting new patients
    Warszawa, Mazowieckie, 02-781, Poland
  • Local Institution not yet accepting patients
    Gdansk, 80-952, Poland
  • Local Institution accepting new patients
    Milano, 20132, Italy
  • Local Institution accepting new patients
    Milano, 20133, Italy
  • Local Institution accepting new patients
    Milano, 20141, Italy
  • Local Institution accepting new patients
    Rozzano MI, 20089, Italy
  • The Kinghorn Cancer Centre accepting new patients
    Darlinghurst, New South Wales, 2010, Australia
  • Local Institution accepting new patients
    North Sydney, New South Wales, 2146, Australia
  • Local Institution accepting new patients
    Westmead, New South Wales, 2145, Australia
  • Local Institution accepting new patients
    Brisbane, Queensland, 4102, Australia
  • Local Institution accepting new patients
    Clayton, Victoria, 3168, Australia
  • Local Institution accepting new patients
    Melbourne, Victoria, 3000, Australia
  • Local Institution accepting new patients
    Nedlands, Western Australia, 6009, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT02658890
Phase
Phase 1/2
Study Type
Interventional
Last Updated
May 30, 2018