Phase 2 Multicohort Study to Evaluate the Safety and Efficacy of Novel Treatment Combinations in Patients With Recurrent Ovarian Cancer

Trial ID # NCT03574779; OPAL
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Niraparib
Alternate Drug Names MK4827, Zejula
Drugs in Trial Bevacizumab, Niraparib, Dostarlimab
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


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, evaluated per RECIST


Exploratory: prior Bev


ORR: 17.9% (7PR, n=39)
DCR: 76.9% (7PR, 23SD, n=39)
PFS: 7.6 months

Exploratory analysis: prior Bev:
w/ prior bev (n=17): ORR: 6% (1PR)
w/o prior bev (n=22): ORR: 27% (6PR)

Clinically Significant Adverse Events

Serious AE: thrombocytopenia (7.3%), anemia (4.9%), hypertension (4.9%)
Grade 3-4 AE: hypertension (22.0%), fatigue (17.1%), anemia (17.1%), 1 grade 4 bowel perforation assessed as related to Bev


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


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

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