| Trial ID # | NCT03574779 |
| Phase | II |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-1 |
| Drug Name | Dostarlimab |
| Alternate Drug Names | TSR-042, anti-PD-1 monoclonal antibody TSR-042, ANB011 |
| Drugs in Trial | Dostarlimab, Bevacizumab, Niraparib |
| Eligible Participant | Platinum resistant or refractory ovarian cancer with no prior PARP inhibitor or PD-1/PD-L1 inhibitor |
| Patients Enrolled | 41; median 2 prior therapies; 44% primary platinum resistant; 90% BRCA WT or unknown; 83% w/o HRR gene mutations or unknown |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, PFS, evaluated per RECIST |
| Biomarkers | Exploratory: prior Bev |
| Efficacy | ORR: 17.9% (7PR, n=39) Exploratory analysis: prior Bev: |
| Clinically Significant Adverse Events | Serious AE: thrombocytopenia (7.3%), anemia (4.9%), hypertension (4.9%) |
| Conclusion | Triplet therapy with dostarlimab, niraparib and bevacizumab is tolerable and demonstrates clinical activity in patients with BRCA WT platinum resistant ovarian cancer without HRR gene mutations |
| Reference | Liu J et al. An open-label phase II study of dostarlimab (TSR-042), bevacizumab (bev), and niraparib combination in patients (pts) with platinum-resistant ovarian cancer (PROC): Cohort A of the OPAL trial. SGO (2021) abstract 10415 Liu J et al. Poster |