NCT04884360 (MONO-OLA1) is a Phase 3 clinical trial of Olaparib in Ovarian Cancer, sponsored by AstraZeneca.

Who is sponsoring NCT04884360?

NCT04884360 is sponsored by AstraZeneca.

What drugs are being tested in NCT04884360?

Interventions in NCT04884360: Olaparib, Matching placebo.

What condition does NCT04884360 study?

NCT04884360 studies Ovarian Cancer.

Is NCT04884360 still recruiting?

NCT04884360 is currently active, enrolled. Last updated 2 March 2026.

Last reviewed 2026-03-02 · How we verify

NCT04884360: MONO-OLA1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

D9319C00001- 1L OC Mono Global RCT

Active, enrolled Phase 3 Last updated 2 March 2026

What this trial tests

Phase 3 trial testing Olaparib in Ovarian Cancer in 366 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 May 2021

Primary endpoint
27 July 2026

27 July 2027

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	366
Start date	31 May 2021
Primary completion	27 July 2026
Estimated completion	27 July 2027
Sites	89 locations across Colombia, South Africa, Russia, Ukraine, Peru, Chile, Vietnam, China

Drugs / interventions tested

Olaparib (olaparib) — full drug profile →
Matching placebo — full drug profile →

Conditions studied

Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

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

Sponsor's own description

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.

Publications & conference data

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

AdvanTIG-202: A phase 2 study investigating anti-T cell immunoglobulin and ITIM domain monoclonal antibody ociperlimab plus tislelizumab in patients with previously treated recurrent or metastatic cervical cancer (333)
Wu L, Wang P, Hsiao S, Chang C, et al · · 2022
COVID-19 pandemic facilitate the adoption of Enhanced Recovery After Surgery in a public hospital in Korea (332)
Kim T, Lee T. · · 2022

Verify or expand the search:

Other trials of Olaparib

Trials testing the same drug.

NCT05522491 — Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Br · Phase 2 · not yet recruiting
NCT05128734 — Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC) · Phase 2 · not yet recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07407452 — Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Che · Phase 2 · not yet recruiting
NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting

Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04884360 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 2 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04884360.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing