A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Trial ID #	NCT02598960
Phase	IIa
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name	Nivolumab
Alternate Drug Names	BMS-936558, ONO-4538, MDX-1106, Anti-PD-1 human mab MDX-1106, Opdivo
Drugs in Trial	BMS-986156, Nivolumab
Eligible Participant	Advanced solid tumors
Patients Enrolled	258; median 2 prior therapies (44 ovarian)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, evaluated per RECIST
Efficacy	37 evaluable ovarian (expansion: 240 mg BMS-986156+ 240 mg nivolumab): ORR: 2.7% DCR: 51.4%
Clinically Significant Adverse Events	Serious AE: all (2.7%) Grade 3-4 AE: all (9.4%)
Conclusion	Nivolumab+BMS-986156 is safe and has efficacy comparable to historical data reported for nivolumab monotherapy
Reference	Heinhuis KM et al. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor–Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol (2019) 6(1):1-8 https://www.ncbi.nlm.nih.gov/pubmed/31697308