A Randomized Study of Paclitaxel – Carboplatin followed by maintenance Niraparib compared to Paclitaxel – Carboplatin – Bevacizumab followed by maintenance Niraparib + Bevacizumab in Patients With Advanced Ovarian Cancer Following a Front-Line Complete Cytoreductive Surgery (NIRVANA-1 study)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504166-37-00

Acronym

GINECO-OV129b

Enrollment

336

Registered

2024-06-25

Start date

2022-02-01

Completion date

Unknown

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced ovarian, tubal or peritoneal cancer.

Brief summary

Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first.

Detailed description

Progression Free Survival (PFS), Progression Free Survival 2 (PFS2), Safety (assessed based on CTCAE version 5), Time to First Subsequent Treatment (TFST), Time to Second Subsequent Treatment (TSST), Overall survival (OS) at 5 years, Confirm the predictive value (overall chemo-sensitivity) of the KELIM (CA-125 Elimination rate constant K)

Interventions

DRUGZejula 100 mg hard capsules

DRUGMVASI 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first.	—

Secondary

Measure	Time frame
Progression Free Survival (PFS), Progression Free Survival 2 (PFS2), Safety (assessed based on CTCAE version 5), Time to First Subsequent Treatment (TFST), Time to Second Subsequent Treatment (TSST), Overall survival (OS) at 5 years, Confirm the predictive value (overall chemo-sensitivity) of the KELIM (CA-125 Elimination rate constant K)	—

Countries

Belgium, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026