A Phase 1/2a Study of BMS-986179 Administered in Combination with Nivolumab (BMS- 936558) in Subjects with Advanced Solid Tumors

Protocol: 
AAAQ8652
Phase: 
I/II

A Phase 1/2a Study of BMS-986179 Administered in Combination with Nivolumab (BMS- 936558) in Subjects with Advanced Solid Tumors

The purpose of the study is to test the safety, anti-tumor activity, and the ability of a new investigational drug called BMS-986179 (also known as anti-CD73) plus nivolumab (also known as BMS-936558) to block the protein CD73 from producing high amounts of a product known as adenosine which blocks your immune system from killing your cancer cells. Nivolumab is an anti-cancer drug that has been approved in the US, Canada and other countries for several different type of cancer. In Part 1A (dose escalation), inhibition of CD73 protein and tolerability of anti-CD73 at various doses plus nivolumab will be tested. In Part 1B (PD sub-study), various doses and dose schedules of anti-CD73 plus nivolumab that are safe and display good levels of CD73 inhibition will be tested. In Part 2 (cohort expansion), the dose and dose schedule identified in Part 1B will be tested in more subjects with specific tumor types to gain additional information about the safety and anti-tumor activity of the study drugs.

Are you Eligible? (Inclusion Criteria)

1. Subjects must be at least 18 years old and have histologic or cytologic
confirmation of a malignancy that is advanced (metastatic and/or unresectable)
with measureable disease per RECIST v1.1 (see Appendix 2) and have at least 1
lesion that is biopsy-accessible.
2. Subjects who have had prior exposure to therapy with any agent specifically
targeting checkpoint pathway inhibition (such as anti-PD-1, anti-PD-L1, anti-PD-
L2, anti-LAG-3, and anti-CTLA-4 antibody) are permitted after a washout period of
any time greater than 4 weeks from the last treatment.
3. Prior palliative radiotherapy must have been completed at least 2 weeks prior
to first dose of the study drug.
4. Subject must consent to a pre-treatment tumor biopsy. Subjects must also
consent to the acquisition of existing formalin-fixed paraffin-embedded tumor
tissue (if available), either a block or 15 to 20 unstained slides, for
performance of correlative studies.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States