Trial ID # | NCT03574779 |
Phase | II |
Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
Drug Name | Niraparib |
Alternate Drug Names | MK4827, Zejula |
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 niraparib, dostarlimab, 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 |