A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL)

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


Study Design

Open-Label, Non-randomized


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


Exploratory: prior Bev


ORR: 17.1% (1CR, 6PR)
DCR: 73.2% (1CR, 6PR, 23SD)
PFS: 7.9 months
DoR: 11.8 months
OS: 22.1 months

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

Clinically Significant Adverse Events

Serious AE: thrombocytopenia (7.3%), anemia (4.9%), hypertension (4.9%)
Grade 3-4 AE: hypertension (26.8%), 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 moderate clinical activity in patients with BRCA WT platinum resistant ovarian cancer


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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