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 Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
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


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 bevacizumab, niraparib and dostarlimab 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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