A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors

Trial ID #	NCT03666143
Phase	I
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name	Tislelizumab
Alternate Drug Names	anti-PD-1 monoclonal antibody BGB-A317, BGB-A317
Drugs in Trial	Tislelizumab, Sitravatinib
Eligible Participant	Platinum resistant ovarian cancer
Patients Enrolled	60; median 4 prior therapies (1-11); 35% w/ prior bevacizumab
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 26% (14PR, n=53) DCR: 77% (14PR, 27SD, n=53) DoR: 4.7 months PFS: 4.1 months OS: 12.9 months
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: hypertension (18%), abdominal pain (12%), fatigue (10%), increased transaminases (10%)
Conclusion	Combination treatment with tislelizumab and sitravatinib is manageable and shows promising antitumor activity
Reference	Goh J et al. Safety/tolerability and preliminary antitumor activity of sitravatinib plus tislelizumab in patients with advanced platinum-resistant ovarian cancer (PROC).AACR (2021) abstract CT013 and presentation https://www.clearityfoundation.org/wp-content/uploads/2021/04/SitravatinibTislelizumab-Goh-Abtract-CT013-AACR-2021.pdf