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 Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name Sitravatinib
Alternate Drug Names MGCD516, multitargeted kinase inhibitor MGCD516
Drugs in Trial Sitravatinib, Tislelizumab
Eligible Participant

Platinum resistant ovarian cancer, no prior checkpoint inhibitor

Patients Enrolled

60; median 4 prior therapies (1-11); 35% w/ prior bevacizumab

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, OS, evaluated per RECIST


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%)


Combination treatment with sitravatinib and tislelizumab is manageable and shows promising antitumor activity


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

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