An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumors

In brief

The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

Key facts

Study ID

NCT02598960

Run by

Bristol-Myers Squibb

People needed

295

Starts

2015-10-14

Expected to finish

2019-12-16

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Dose Escalation:
• Subjects with any previously treated advanced (metastatic or refractory) solid tumor
• For Cohort Expansion:
• Subjects must have a previously treated advanced solid tumor to be eligible
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
• Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

You may not qualify if…

• Known central nervous system metastases or central nervous system as the only source of disease
• Other concomitant malignancies (with some exceptions per protocol)
• Active, known or suspected autoimmune disease
• Uncontrolled or significant cardiovascular disease
• History of active or chronic hepatitis (e.g. Hep B or C)
• Impaired liver or bone marrow function
• Major surgery less than 1 month before start of the study

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• Emory University — Atlanta, Georgia, United States
• The Ohio State University — Columbus, Ohio, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• The West Clinic, P.C. — Germantown, Tennessee, United States
• Liverpool Cancer Therapy Center — Liverpool, New South Wales, Australia
• Local Institution — Westmead, New South Wales, Australia
• Princess Alexandra Hospital — Brisbane, Queensland, Australia
• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia
• Local Institution - 0012 — Ghent, Belgium
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Paris, France
• Institut Claudius Regaud — Toulouse, France
• Institut Gustave Roussy — Vlllejuif, France
• Local Institution — Bonn, Germany
• Local Institution — Freiburg im Breisgau, Germany
• Local Institution — Würzburg, Germany
• Local Institution - 0015 — Milan, Lombardy, Italy
• Local Institution - 0014 — Milan, Italy
• Local Institution — Amsterdam, Netherlands
• Local Institution — Madrid, Spain
• Local Institution — Madrid, Spain

Full record on ClinicalTrials.gov

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