A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Trial ID #	NCT01975831
Phase	I
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-L1
Drug Name	Durvalumab
Alternate Drug Names	Anti-B7H1 Monoclonal Antibody MEDI4736, MEDI4736, Imfinzi
Drugs in Trial	Durvalumab, Tremelimumab
Eligible Participant	Advanced solid tumors
Patients Enrolled	104 (30 ovarian)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, evaluated per irRECIST
Efficacy	ORR: 7.4% (2PR, n=27) DCR: 44.4% (2PR, 10SD, n=27) DoR: 10.8 months (5.6-15.9 months)
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: any (14.4%)
Conclusion	Durvalumab+tremelimumab has a manageable safety profile with preliminary evidence of clinical activity
Reference	Callahan MK et al. Phase 1 study to evaluate the safety and tolerability of MEDI4736 (durvalumab, DUR) + tremelimumab (TRE) in patients with advanced solid tumors. J Clin Oncol (2017) 35 (suppl; abstr 3069) https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.3069 Callahan MK et al. Poster https://www.clearityfoundation.org/wp-content/uploads/2020/03/NCT01975831_Callahan_ASCO2017_Poster.pdf