NCT02354131: AVANOVA

Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer

Completed Phase 1, PHASE2 Last updated 30 August 2022

What this trial tests

Phase 1, PHASE2 trial testing Niraparib in Ovarian Cancer in 108 participants. Completed in 15 December 2021.

Timeline

15 February 2015

Primary endpoint
15 November 2018

15 December 2021

Quick facts

Lead sponsor	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	108
Start date	15 February 2015
Primary completion	15 November 2018
Estimated completion	15 December 2021
Sites	2 locations across Denmark, United States

Drugs / interventions tested

• Niraparib (niraparib) — full drug profile →
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS)

PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease.

In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone.

The question is:

Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in ovarian cancer therapy.
   Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. · · 2018 · cited 417× · PMID 29249039 · DOI 10.1007/s00280-017-3501-8
2. Exploring and comparing adverse events between PARP inhibitors.
   LaFargue CJ, Dal Molin GZ, Sood AK, Coleman RL. · · 2019 · cited 367× · PMID 30614472 · DOI 10.1016/s1470-2045(18)30786-1
3. Anti-Angiogenic Therapy: Current Challenges and Future Perspectives.
   Lopes-Coelho F, Martins F, Pereira SA, Serpa J. · · 2021 · cited 254× · PMID 33916438 · DOI 10.3390/ijms22073765
4. Targeting the tumor stroma for cancer therapy.
   Xu M, Zhang T, Xia R, Wei Y, et al · · 2022 · cited 195× · PMID 36324128 · DOI 10.1186/s12943-022-01670-1
5. Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial.
   Mirza MR, Åvall Lundqvist E, Birrer MJ, dePont Christensen R, et al · · 2019 · cited 194× · PMID 31474354 · DOI 10.1016/s1470-2045(19)30515-7
6. Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
   Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
7. PARP inhibitors: Clinical utility and possibilities of overcoming resistance.
   Bitler BG, Watson ZL, Wheeler LJ, Behbakht K. · · 2017 · cited 161× · PMID 29037806 · DOI 10.1016/j.ygyno.2017.10.003
8. PARP inhibitors for BRCA1/2-mutated and sporadic ovarian cancer: current practice and future directions.
   Konecny GE, Kristeleit RS. · · 2016 · cited 155× · PMID 27736844 · DOI 10.1038/bjc.2016.311