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

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)
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

Conclusion

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

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
https://www.clearityfoundation.org/wp-content/uploads/2021/03/SGO-10415-Liu-OPAL-NirBevDos.pdf

Liu J et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2021/03/SGO-OPAL-poster.pdf

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