| Trial ID # | NCT03574779; OPAL |
| 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 | Bevacizumab, Dostarlimab, 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, DoR, PFS, OS, evaluated per RECIST |
| Biomarkers | Exploratory: prior Bev |
| Efficacy | ORR: 17.1% (1CR, 6PR) Exploratory analysis: prior Bev: |
| Clinically Significant Adverse Events | Serious AE: thrombocytopenia (7.3%), anemia (4.9%), hypertension (4.9%) |
| Conclusion | Triplet therapy with niraparib, dostarlimab, and bevacizumab is tolerable and demonstrates moderate clinical activity in patients with BRCA WT platinum resistant ovarian cancer |
| Reference | Liu JF et al. Niraparib, Dostarlimab, and Bevacizumab as Combination Therapy in Pretreated, Advanced Platinum-Resistant Ovarian Cancer: Findings From Cohort A of the OPAL Phase II Trial. JCO Precis Oncol (2024) 8:e2300693 |
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